YSI Incorporated
YSI 1531C Standard (D- Glucose 900mg/dL, 50 mmol/L, 9.00 g/L)
8manufacturers in China registered for this device type
34catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Shenzhen Yuwen E-Commerce Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 19 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
Record
| Listed by | YSI Incorporated, United States |
|---|---|
| FDA product code | CGA |
| Device type | Glucose Oxidase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K210933 |
| Record published | 2016-12-31 |
| Record revised | 2022-10-10 (version 5) |
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, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1515 | In distribution | |
| 2900C | In distribution | |
| 2355 | In distribution | |
| 2329C | In distribution | |
| 2328 | In distribution | |
| 2325 | In distribution | |
| 2329 | In distribution | |
| 2315 | In distribution | |
| 2368 | In distribution | |
| 2324 | In distribution | |
| 2356 | In distribution | |
| 1530C | In distribution | |
| 1531 | In distribution | |
| 1530 | In distribution | |
| 2367 | In distribution | |
| 2327C | In distribution | |
| 2392C | In distribution | |
| 2363C | In distribution | |
| 2747 | In distribution | |
| 2357 | In distribution | |
| 2327 | In distribution | |
| 2356C | In distribution | |
| 2368C | In distribution | |
| 1531C | In distribution | |
| 2365 | In distribution | |
| 2363 | In distribution | |
| 2328C | In distribution | |
| 2747C | In distribution | |
| 2357C | In distribution | |
| 2392 | In distribution | |
| 2365C | In distribution | |
| 2323 | In distribution | |
| 1504 | In distribution | |
| 2367C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| i-STAT | Abbott Point OF Care Inc. | 48 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 28 |
| Stat Profile | Nova Biomedical Corporation | 17 |
| Fora | Fora Care Inc. | 13 |
| TRUEtrack | Trividia Health, Inc. | 12 |
| JAS Diagnostics | Drew Scientific, Ltd. | 11 |
| StatStrip | Nova Biomedical Corporation | 9 |
| Gluc-PAP | Randox Laboratories Limited | 8 |
| Nova Primary | Nova Biomedical Corporation | 8 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| Prodigy No Coding Blood Glucose Test Strips | Prodigy Diabetes Care, LLC | 7 |
| StatSensor/StatStrip | Nova Biomedical Corporation | 6 |
Showing 12 of 215. All products under Glucose Oxidase, Glucose
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210933 | 2024-09-30 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P990026 | 2002-02-04 | CYGNUS GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. |
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.