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

Gram Negative Identification Panel

21 CFR 866.2660 / Microbiology
FDA source (opens on fda.gov)

LQM is the FDA product code for Gram Negative Identification Panel, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
LQM
Device name
Gram Negative Identification Panel
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
2

Clearances, product code LQM

By decision year
7 clearances under product code LQM with a decision year between 1985 and 1993, 1991 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LQM by decision year
YearClearances
19851
19861
19891
19912
19932

Applicants with the most clearances

Product code LQM
Applicants holding the most 510(k) clearances under product code LQM
ApplicantClearances
American Micro Scan1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Biomerieux Vitek, Inc.1
Pasco Laboratories, Inc.1
Radiometer America, Inc1
Roche Diagnostic Systems, Inc.1
Vitek Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code