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

Radioimmunoassay, Amikacin

21 CFR 862.3035 / Clinical Toxicology
FDA source (opens on fda.gov)

KLQ is the FDA product code for Radioimmunoassay, Amikacin, a class II device type, regulated under 21 CFR 862.3035. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KLQ
Device name
Radioimmunoassay, Amikacin
Regulation
21 CFR 862.3035
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
20
Ingested recalls
0

Clearances, product code KLQ

By decision year
20 clearances under product code KLQ with a decision year between 1978 and 2005, 1980 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KLQ by decision year
YearClearances
19781
19804
19811
19824
19831
19843
19851
19891
19901
19961
20041
20051

Applicants with the most clearances

Product code KLQ
Applicants holding the most 510(k) clearances under product code KLQ
ApplicantClearances
Siemens Healthcare Diagnostics Inc.3
Miles Laboratories, Inc.2
Abbott Medical1
American Dade1
American Diagnostic Corp.1
Antibodies, Inc.1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Colony Laboratories, Inc.1
E.I. Dupont de Nemours & Co., Inc.1
Innotron of Oregon, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code