Cyanomethemoglobin Reagent And Standard Solution
Cyanomethemoglobin Reagent and Standard Solution (product code GJZ) is a hematology reagent system used in the cyanmethemoglobin (Drabkin's) method for photometric hemoglobin measurement, in which the reagent converts hemoglobin derivatives to cyanmethemoglobin for quantification against a stable standard solution. 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
- GJZ
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.