Remel
Potassium Hydroxide (KOH) 10% BTL/25ml
4manufacturers in China registered for this device type
62catalogue numbers in this listing
49510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Jilin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
| Zhejiang Joozena Medical Technology Co., Ltd. | Dongyang City, Jinhua | Zhejiang | Manufacturer | 5 |
Record
| Listed by | Remel, Inc., United States |
|---|---|
| FDA product code | JTO |
| Device type | Discs, Strips And Reagents, Microorganism Differentiation |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-01-03 |
| Record revised | 2023-01-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-04-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| R21251 | In distribution | ||
| R21230 | In distribution | ||
| R21137 | In distribution | ||
| R21130 | In distribution | ||
| R21258 | In distribution | ||
| R8311003 | 20 | In distribution | |
| R211820 | In distribution | ||
| R21138 | In distribution | ||
| R21115 | In distribution | ||
| R21126 | In distribution | ||
| R21140 | In distribution | ||
| R21156 | In distribution | ||
| R21227 | In distribution | ||
| R8311008 | 20 | In distribution | |
| R21281 | In distribution | ||
| R21122 | In distribution | ||
| R8309003 | In distribution | ||
| R40222 | In distribution | ||
| R8309009 | In distribution | ||
| R21206 | In distribution | ||
| R062085 | In distribution | ||
| R30854401 | In distribution | ||
| R21123 | In distribution | ||
| R8311009 | 20 | In distribution | |
| R21238 | In distribution | ||
| R21134 | In distribution | ||
| R211357 | In distribution | ||
| R30854301 | In distribution | ||
| R211356 | In distribution | ||
| R40061 | In distribution | ||
| R30168501 | 50 | In distribution | |
| R21239 | In distribution | ||
| R21218 | In distribution | ||
| R21231 | In distribution | ||
| R211172 | In distribution | ||
| R21132 | In distribution | ||
| R21200 | In distribution | ||
| R211667 | In distribution | ||
| R21245 | In distribution | ||
| R21135 | In distribution | ||
| R21093 | In distribution | ||
| R21087 | In distribution | ||
| R8309002 | In distribution | ||
| R21242 | In distribution | ||
| R21121 | In distribution | ||
| R261605 | In distribution | ||
| R249348 | In distribution | ||
| R21213 | In distribution | ||
| R8309004 | In distribution | ||
| R01554 | In distribution | ||
| R21129 | In distribution | ||
| R211173 | In distribution | ||
| R21120 | In distribution | ||
| R02382 | Withdrawn | ||
| R21244 | Withdrawn | ||
| R21221 | Withdrawn | ||
| R21201 | Withdrawn | ||
| R21209 | Withdrawn | ||
| R21211 | Withdrawn | ||
| R21243 | Withdrawn | ||
| R21395 | Withdrawn | ||
| R21254 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discs, Strips And Reagents, Microorganism Differentiation | Hardy Diagnostics | 37 |
| HardyDisk™ | Hardy Diagnostics | 17 |
| Bactidrop | Remel, Inc. | 10 |
| Redipor | Analytichem USA, Inc. | 7 |
| BD BBL™ Taxo™ P | Becton, Dickinson AND Company | 4 |
| BD BBL™ Taxo™ A | Becton, Dickinson AND Company | 4 |
| API® NaCl 0.85% Medium | bioMerieux, Inc. | 3 |
| Bacticard | Remel, Inc. | 3 |
| Chemmette Reagents | Microbiologics, Inc. | 2 |
| Optochin | Oxoid, Ltd. | 2 |
| X Factor | Oxoid, Ltd. | 2 |
| X & V Factor | Oxoid, Ltd. | 2 |
Showing 12 of 139. All products under Discs, Strips And Reagents, Microorganism Differentiation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K970832 | 1997-04-24 |
| K970834 | 1997-04-17 |
| K970833 | 1997-04-02 |
| K936021 | 1994-05-20 |
| K934986 | 1994-02-23 |
| K933514 | 1993-10-28 |
| K930878 | 1993-05-11 |
| K923700 | 1992-10-05 |
| K923827 | 1992-09-28 |
| K920973 | 1992-06-19 |
| K920971 | 1992-05-22 |
| K920972 | 1992-05-22 |
| K920257 | 1992-04-22 |
| K913008 | 1991-09-23 |
| K913002 | 1991-09-23 |
| K913007 | 1991-09-23 |
| K913003 | 1991-09-23 |
| K913006 | 1991-09-23 |
| K913011 | 1991-09-19 |
| K913010 | 1991-09-19 |
| K913001 | 1991-09-18 |
| K913009 | 1991-09-18 |
| K913004 | 1991-09-18 |
| K905163 | 1991-02-20 |
| K905151 | 1991-01-25 |
| K902595 | 1990-10-02 |
| K880950 | 1988-04-01 |
| K861259 | 1986-04-11 |
| K852886 | 1985-07-23 |
| K844020 | 1984-12-13 |
| K844019 | 1984-10-31 |
| K843987 | 1984-10-30 |
| K840686 | 1984-04-13 |
| K840708 | 1984-04-13 |
| K840614 | 1984-04-13 |
| K840819 | 1984-03-23 |
| K840483 | 1984-03-02 |
| K834022 | 1983-12-30 |
| K834029 | 1983-12-30 |
| K833963 | 1983-12-30 |
| K834028 | 1983-12-30 |
| K830323 | 1983-02-28 |
| K812084 | 1981-08-13 |
| K812083 | 1981-08-13 |
| K812082 | 1981-08-13 |
| K810541 | 1981-03-17 |
| K801493 | 1980-08-13 |
| K801492 | 1980-08-13 |
| K790038 | 1979-01-26 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-05-02 | Class II | Process control | The product may give weak or false negative test results. | 109 kits | 2014-03-12 |
| 2013-05-02 | Class II | Process control | The product may give weak or false negative test results. | 768 kits | 2014-03-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.