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

Reagent, Immunoassay, Igg

21 CFR 866.5530 / Immunology
FDA source (opens on fda.gov)

KTO is the FDA product code for Reagent, Immunoassay, Igg, a class I device type, regulated under 21 CFR 866.5530. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
KTO
Device name
Reagent, Immunoassay, Igg
Regulation
21 CFR 866.5530
Device class
Class I
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
2

Clearances, product code KTO

By decision year
2 clearances under product code KTO with a decision year between 1985 and 1989, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KTO by decision year
YearClearances
19851
19891

Applicants with the most clearances

Product code KTO
Applicants holding the most 510(k) clearances under product code KTO
ApplicantClearances
Kallestad Laboratories, Inc.1
Reagents Applications, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code