Oxyhemoglobin
Oxyhemoglobin (product code GGZ) is a hematology reagent or standard used in photometric assays for measuring hemoglobin concentration in blood, utilizing the characteristic light absorption of the oxygenated form of hemoglobin. 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
- GGZ
- 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 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.