GIQ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hemoglobin S
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7415
- 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 |
|---|---|---|
| SICKLE-2000 (K955719) | Medicus Technologies, Inc. | 1996-08-14 |
| QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY (K942276) | Isolab, Inc. | 1995-01-20 |
| HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 (K874429) | Hf Scientific, Inc. | 1988-02-04 |
Track GIQ automatically
Every clearance here is in the API, with alerts when new ones post.