FDA product code KQF: Assay, Glutathione Reductase
KQF is the FDA product code for assay, glutathione reductase. It is a Class II device, regulated under 21 CFR 864.7375 and reviewed by the Hematology panel. Devices under KQF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Assay, Glutathione Reductase |
| Device class | Class II |
| Regulation | 21 CFR 864.7375 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for KQF devices
openFDA lists no recalls for product code KQF.
Frequently asked questions
What is FDA product code KQF?
KQF is the FDA product code for assay, glutathione reductase. It is a Class II device, regulated under 21 CFR 864.7375 and reviewed by the Hematology panel.
What device class is KQF?
Class II, regulation 21 CFR 864.7375. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KQF
- Run a recall and safety report across every KQF manufacturer
- Watch product code KQF 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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