GFS
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Standards And Controls, Hemoglobin, Normal And Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Medical specialty
- Hematology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL (K023032) | Bioresource Technology, Inc. | 2002-10-08 |
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Every clearance here is in the API, with alerts when new ones post.