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

Fluorescent Immunoassay Gentamicin

21 CFR 862.3450 / Clinical Toxicology
FDA source (opens on fda.gov)

LCQ is the FDA product code for Fluorescent Immunoassay Gentamicin, a class II device type, regulated under 21 CFR 862.3450. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
LCQ
Device name
Fluorescent Immunoassay Gentamicin
Regulation
21 CFR 862.3450
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
19
Ingested recalls
3

Clearances, product code LCQ

By decision year
19 clearances under product code LCQ with a decision year between 1979 and 1997, 1980 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LCQ by decision year
YearClearances
19791
19803
19812
19821
19842
19853
19891
19901
19911
19941
19951
19961
19971

Applicants with the most clearances

Product code LCQ
Applicants holding the most 510(k) clearances under product code LCQ
ApplicantClearances
Abbott Medical2
Roche Diagnostic Systems, Inc.2
American Diagnostic Corp.1
Bio-Rad1
Bioprobe Intl., Inc.1
Colony Laboratories, Inc.1
Hospitax1
Innotron Diagnostics1
Intl. Diagnostic Technology1
Miles Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code