FDA product code GKK: Cyanomethemoglobin
GKK is the FDA product code for cyanomethemoglobin. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel. FDA has cleared 7 510(k) submissions under GKK, from 7 different applicants. The average 510(k) review took 41 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | Cyanomethemoglobin |
| Device class | Class II |
| Regulation | 21 CFR 864.7500 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GKK clearance
Top GKK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Reagents Applications, Inc. | 1 | 1990-01-25 |
| Macomb Biotechnology, Inc. | 1 | 1989-10-24 |
| Kvm Technologies, Inc. | 1 | 1988-10-12 |
| Omega Medical Electronics | 1 | 1982-05-24 |
| J.T. Baker Chemical Co. | 1 | 1977-09-20 |
2 more applicants have GKK clearances. See the full list in Caduvo.
Most recent GKK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896922 | Reagents Applications, Inc. | RAICHEM TM HEMOGLOBIN REAGENT | 1990-01-25 | 45 |
| K894951 | Macomb Biotechnology, Inc. | MODIFIED HEMOGLOBIN REAGENT SET | 1989-10-24 | 96 |
| K883992 | Kvm Technologies, Inc. | KVM PREPACK HEMATOLOGY REAGENT SET | 1988-10-12 | 22 |
| K821202 | Omega Medical Electronics | HEMOGLOBIN REAGENT SET | 1982-05-24 | 27 |
| K771716 | J.T. Baker Chemical Co. | CYMET-PLUS | 1977-09-20 | 8 |
Recalls for GKK devices
openFDA lists no recalls for product code GKK.
Frequently asked questions
What is FDA product code GKK?
GKK is the FDA product code for cyanomethemoglobin. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel.
What device class is GKK?
Class II, regulation 21 CFR 864.7500. Typical premarket route: 510(k).
How long does a 510(k) take for product code GKK?
Across 7 cleared submissions the average was 41 days from receipt to decision (median 27).
Which companies have the most GKK clearances?
Reagents Applications, Inc. (1); Macomb Biotechnology, Inc. (1); Kvm Technologies, Inc. (1); Omega Medical Electronics (1); J.T. Baker Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GKK
- Run a recall and safety report across every GKK manufacturer
- Watch product code GKK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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