GFS — Standards And Controls, Hemoglobin, Normal And Abnormal Class II
FDA product code GFS covers "Standards And Controls, Hemoglobin, Normal And Abnormal", a Class II medical device regulated under 21 CFR 864.8625. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- GFS
- Device Class
- Class II
- Regulation Number
- 864.8625
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K023032 | bioresource technology | LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL | October 8, 2002 |