FDA product code KTM: C3-Indirect Immunofluorescent Solid Phase
KTM is the FDA product code for c3-indirect immunofluorescent solid phase. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel. Devices under KTM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | C3-Indirect Immunofluorescent Solid Phase |
| Device class | Class II |
| Regulation | 21 CFR 866.5240 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for KTM devices
openFDA lists no recalls for product code KTM.
Frequently asked questions
What is FDA product code KTM?
KTM is the FDA product code for c3-indirect immunofluorescent solid phase. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel.
What device class is KTM?
Class II, regulation 21 CFR 866.5240. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code KTM
- Run a recall and safety report across every KTM manufacturer
- Watch product code KTM 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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