FDA product code GFS: Standards And Controls, Hemoglobin, Normal And Abnormal
GFS is the FDA product code for standards and controls, hemoglobin, normal and abnormal. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under GFS. The average 510(k) review took 27 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | Standards And Controls, Hemoglobin, Normal And Abnormal |
| Device class | Class II |
| Regulation | 21 CFR 864.8625 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GFS clearance
Top GFS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bioresource Technology, Inc. | 1 | 2002-10-08 |
Most recent GFS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023032 | Bioresource Technology, Inc. | LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL | 2002-10-08 | 27 |
Recalls for GFS devices
openFDA lists no recalls for product code GFS.
Frequently asked questions
What is FDA product code GFS?
GFS is the FDA product code for standards and controls, hemoglobin, normal and abnormal. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel.
What device class is GFS?
Class II, regulation 21 CFR 864.8625. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GFS?
Across 1 cleared submissions the average was 27 days from receipt to decision (median 27).
Which companies have the most GFS clearances?
Bioresource Technology, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GFS
- Run a recall and safety report across every GFS manufacturer
- Watch product code GFS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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