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

Radioassay, Angiotensin Converting Enzyme

21 CFR 862.1090 / Clinical Chemistry
FDA source (opens on fda.gov)

KQN is the FDA product code for Radioassay, Angiotensin Converting Enzyme, a class II device type, regulated under 21 CFR 862.1090. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KQN
Device name
Radioassay, Angiotensin Converting Enzyme
Regulation
21 CFR 862.1090
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code KQN

By decision year
8 clearances under product code KQN with a decision year between 1979 and 2004, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KQN by decision year
YearClearances
19791
19821
19841
19862
19911
19941
20041

Applicants with the most clearances

Product code KQN
Applicants holding the most 510(k) clearances under product code KQN
ApplicantClearances
American Laboratory Products Company2
Ventrex Laboratories, Inc.2
Biotecx Laboratories, Inc.1
Hana Biologics, Inc.1
Sigma Diagnostics, Inc.1
Thermo Electron Oy1

Companies listing this code with FDA

Companies whose registered establishments list this code