510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KTPClass II

Complement C3b Activator Immunoassay Reagents

21 CFR 866.5260 / Immunology
FDA source (opens on fda.gov)

KTP is the FDA product code for Complement C3b Activator Immunoassay Reagents, a class II device type, regulated under 21 CFR 866.5260. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
KTP
Device name
Complement C3b Activator Immunoassay Reagents
Regulation
21 CFR 866.5260
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code KTP

By decision year
1 clearance under product code KTP with a decision year between 1979 and 1979, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KTP by decision year
YearClearances
19791

Applicants with the most clearances

Product code KTP
Applicants holding the most 510(k) clearances under product code KTP
ApplicantClearances
Icl Scientific1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code KTP.