Standards And Controls, Hemoglobin, Normal And Abnormal
Standards and Controls, Hemoglobin, Normal and Abnormal (product code GFS) are reference materials used to calibrate and quality-control laboratory instruments and assays that measure hemoglobin levels in blood, supporting the diagnosis of anemia and other hematological conditions. This device is classified as FDA Class 2, indicating moderate risk, and does not require premarket notification under the current classification. Regulated under 21 CFR 864.8625 in the Hematology specialty (HE), this device carries no flags for implantation, life support, GMP exemption, or third-party review.
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Basic Information
- Product Code
- GFS
- Device Class
- FDA class 2
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K023032 | LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL | Oct 08, 2002 | Substantially Equivalent | Bioresource Technology, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.