FDA product code KTK: Reagent, Immunoassay, Carbonic Anhydrase B And C
KTK is the FDA product code for reagent, immunoassay, carbonic anhydrase b and c. It is a Class I device, regulated under 21 CFR 866.5200 and reviewed by the Hematology panel. Devices under KTK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Reagent, Immunoassay, Carbonic Anhydrase B And C |
| Device class | Class I |
| Regulation | 21 CFR 866.5200 |
| Review panel | HE — Hematology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for KTK devices
openFDA lists no recalls for product code KTK.
Frequently asked questions
What is FDA product code KTK?
KTK is the FDA product code for reagent, immunoassay, carbonic anhydrase b and c. It is a Class I device, regulated under 21 CFR 866.5200 and reviewed by the Hematology panel.
What device class is KTK?
Class I, regulation 21 CFR 866.5200. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KTK
- Run a recall and safety report across every KTK manufacturer
- Watch product code KTK 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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