GKK
7 FDA 510(k) clearances · Product code
27 daysmedian time to decision
96 days90th percentile
7clearances measured
FDA profile
- Official device name
- Cyanomethemoglobin
- 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 |
|---|---|---|
| RAICHEM TM HEMOGLOBIN REAGENT (K896922) | Reagents Applications, Inc. | 1990-01-25 |
| MODIFIED HEMOGLOBIN REAGENT SET (K894951) | Macomb Biotechnology, Inc. | 1989-10-24 |
| KVM PREPACK HEMATOLOGY REAGENT SET (K883992) | Kvm Technologies, Inc. | 1988-10-12 |
| HEMOGLOBIN REAGENT SET (K821202) | Omega Medical Electronics | 1982-05-24 |
| CYMET-PLUS (K771716) | J.T. Baker Chemical Co. | 1977-09-20 |
| UNIPAK HEMOGLOBIN (K771090) | Harleco | 1977-07-11 |
| HEMOTOLOGY PRODU&TS (5 IN ALL) (K770803) | Hycel, Inc. | 1977-07-05 |
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Every clearance here is in the API, with alerts when new ones post.