GIG
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hemoglobinometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7500
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RANDOX BILIRUBIN (K973995) | Randox Laboratories, Ltd. | 1997-12-08 |
| HBM HEMOGLOBINOMETER (K933836) | Artel, Inc. | 1994-03-31 |
| HEMOGLOBIN ANALYZER & PERFORM. CHECK SET (K771101) | The Dow Chemical Co. | 1977-07-21 |
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Every clearance here is in the API, with alerts when new ones post.