FDA product code KHF: Adenine Nucleotide Quantitation
KHF is the FDA product code for adenine nucleotide quantitation. It is a Class I device, regulated under 21 CFR 864.7040 and reviewed by the Hematology panel. Devices under KHF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Adenine Nucleotide Quantitation |
| Device class | Class I |
| Regulation | 21 CFR 864.7040 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for KHF devices
openFDA lists no recalls for product code KHF.
Frequently asked questions
What is FDA product code KHF?
KHF is the FDA product code for adenine nucleotide quantitation. It is a Class I device, regulated under 21 CFR 864.7040 and reviewed by the Hematology panel.
What device class is KHF?
Class I, regulation 21 CFR 864.7040. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KHF
- Run a recall and safety report across every KHF manufacturer
- Watch product code KHF 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.