Remel
Gram Iodine,Enhanced Btl x 5/250ml
1manufacturer
7catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
Record
| Listed by | Remel, Inc., United States |
|---|---|
| FDA product code | HYI |
| Device type | Iodine, Grams |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1850 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R40235 | In distribution | |
| R40231 | In distribution | |
| R40234 | In distribution | |
| R40077 | In distribution | |
| R40056 | In distribution | |
| R40057 | In distribution | |
| R40232 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 2 |
| Gram Stain Core Kit | Ventana Medical Systems, Inc. | 1 |
| Para-Pak C&S in Biobags | Meridian Bioscience, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K871286 | 1987-04-08 |
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.