FDA Product Code
FDA Product Code GKK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7500
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K896922 | RAICHEM TM HEMOGLOBIN REAGENT | Reagents Applications, Inc. | 1990-01-25 | Traditional | PDF ↗ |
| K894951 | MODIFIED HEMOGLOBIN REAGENT SET | Macomb Biotechnology, Inc. | 1989-10-24 | Traditional | PDF ↗ |
| K883992 | KVM PREPACK HEMATOLOGY REAGENT SET | Kvm Technologies, Inc. | 1988-10-12 | Traditional | PDF ↗ |
| K821202 | HEMOGLOBIN REAGENT SET | Omega Medical Electronics | 1982-05-24 | Traditional | PDF ↗ |
| K771716 | CYMET-PLUS | J.T. Baker Chemical Co. | 1977-09-20 | Traditional | PDF ↗ |
| K771090 | UNIPAK HEMOGLOBIN | Harleco | 1977-07-11 | Traditional | PDF ↗ |
| K770803 | HEMOTOLOGY PRODU&TS (5 IN ALL) | Hycel, Inc. | 1977-07-05 | Traditional | PDF ↗ |
Product code GKK · Class II · Hematology. Data: openFDA.