GKK — Cyanomethemoglobin Class II
FDA Device Classification
Classification Details
- Product Code
- GKK
- Device Class
- Class II
- Regulation Number
- 864.7500
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K896922 | reagents applications | RAICHEM TM HEMOGLOBIN REAGENT | January 25, 1990 |
| K894951 | macomb biotechnology | MODIFIED HEMOGLOBIN REAGENT SET | October 24, 1989 |
| K883992 | kvm technologies | KVM PREPACK HEMATOLOGY REAGENT SET | October 12, 1988 |
| K821202 | omega medical electronics | HEMOGLOBIN REAGENT SET | May 24, 1982 |
| K771716 | j.t. baker chemical | CYMET-PLUS | September 20, 1977 |
| K771090 | harleco | UNIPAK HEMOGLOBIN | July 11, 1977 |
| K770803 | hycel | HEMOTOLOGY PRODU&TS (5 IN ALL) | July 5, 1977 |