Cyanomethemoglobin
FDA product code GKK · Class II (moderate risk) · 21 CFR 864.7500 · Hematology
7510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K896922 | Raichem TM Hemoglobin ReagentGKK · Traditional | Reagents Applications, Inc. | 01/25/1990SE |
| K894951 | Modified Hemoglobin Reagent SetGKK · Traditional | Macomb Biotechnology, Inc. | 10/24/1989SE |
| K883992 | KVM Prepack Hematology Reagent SetGKK · Traditional | Kvm Technologies, Inc. | 10/12/1988SE |
| K821202 | Hemoglobin Reagent SetGKK · Traditional | Omega Medical Electronics | 05/24/1982SE |
| K771716 | Cymet-PlusGKK · Traditional | J.T. Baker Chemical Co. | 09/20/1977SE |
| K771090 | Unipak HemoglobinGKK · Traditional | Harleco | 07/11/1977SE |
| K770803 | Hemotology Produ&Ts (5 in All)GKK · Traditional | Hycel, Inc. | 07/05/1977SE |