Cyanomethemoglobin
Cyanomethemoglobin (product code GKK) is a hematology reagent or reference material representing the cyanmethemoglobin form of hemoglobin, used as a stable photometric standard in the quantitative determination of total hemoglobin concentration in blood using the Drabkin's method. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7500 in the Hematology specialty (HE), it is eligible for third-party review.
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Basic Information
- Product Code
- GKK
- Device Class
- FDA class 2
- Regulation Number
- 864.7500
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K896922 | RAICHEM TM HEMOGLOBIN REAGENT | Jan 25, 1990 | Substantially Equivalent | Reagents Applications, Inc. |
| K894951 | MODIFIED HEMOGLOBIN REAGENT SET | Oct 24, 1989 | Substantially Equivalent | Macomb Biotechnology, Inc. |
| K883992 | KVM PREPACK HEMATOLOGY REAGENT SET | Oct 12, 1988 | Substantially Equivalent | Kvm Technologies, Inc. |
| K821202 | HEMOGLOBIN REAGENT SET | May 24, 1982 | Substantially Equivalent | Omega Medical Electronics |
| K771716 | CYMET-PLUS | Sep 20, 1977 | Substantially Equivalent | J.T. Baker Chemical Co. |
| K771090 | UNIPAK HEMOGLOBIN | Jul 11, 1977 | Substantially Equivalent | Harleco |
| K770803 | HEMOTOLOGY PRODU&TS (5 IN ALL) | Jul 05, 1977 | Substantially Equivalent | Hycel, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.