FDA product code KTP: Complement C3b Activator Immunoassay Reagents
KTP is the FDA product code for complement c3b activator immunoassay reagents. It is a Class II device, regulated under 21 CFR 866.5260 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under KTP. The average 510(k) review took 65 days (median 65).
Classification
| Field | Value |
|---|---|
| Device name | Complement C3b Activator Immunoassay Reagents |
| Device class | Class II |
| Regulation | 21 CFR 866.5260 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KTP clearance
Top KTP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Icl Scientific | 1 | 1979-03-15 |
Most recent KTP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K790059 | Icl Scientific | PROACTIVATOR C3, C4 AND C3 | 1979-03-15 | 65 |
Recalls for KTP devices
openFDA lists no recalls for product code KTP.
Frequently asked questions
What is FDA product code KTP?
KTP is the FDA product code for complement c3b activator immunoassay reagents. It is a Class II device, regulated under 21 CFR 866.5260 and reviewed by the Immunology panel.
What device class is KTP?
Class II, regulation 21 CFR 866.5260. Typical premarket route: 510(k).
How long does a 510(k) take for product code KTP?
Across 1 cleared submissions the average was 65 days from receipt to decision (median 65).
Which companies have the most KTP clearances?
Icl Scientific (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KTP
- Run a recall and safety report across every KTP manufacturer
- Watch product code KTP 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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