Panels › Hematology › Product code GKK · Class 2
Cyanomethemoglobin
Regulation 864.7500
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GKK
| Company | 510(k)s | Recalls |
|---|---|---|
| Harleco | 1 | 0 |
| Hycel, Inc. | 1 | 0 |
| J.T. Baker Chemical Co. | 1 | 0 |
| Kvm Technologies, Inc. | 1 | 0 |
| Macomb Biotechnology, Inc. | 1 | 0 |
| Omega Medical Electronics | 1 | 0 |
| Reagents Applications, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 25, 1990 | K896922 | RAICHEM TM HEMOGLOBIN REAGENT Reagents Applications, Inc. | GKK |
| Oct 24, 1989 | K894951 | MODIFIED HEMOGLOBIN REAGENT SET Macomb Biotechnology, Inc. | GKK |
| Oct 12, 1988 | K883992 | KVM PREPACK HEMATOLOGY REAGENT SET Kvm Technologies, Inc. | GKK |
| May 24, 1982 | K821202 | HEMOGLOBIN REAGENT SET Omega Medical Electronics | GKK |
| Sep 20, 1977 | K771716 | CYMET-PLUS J.T. Baker Chemical Co. | GKK |
| Jul 11, 1977 | K771090 | UNIPAK HEMOGLOBIN Harleco | GKK |
| Jul 5, 1977 | K770803 | HEMOTOLOGY PRODU&TS (5 IN ALL) Hycel, Inc. | GKK |
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