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

Gram Positive Identification Panel

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

LQL is the FDA product code for Gram Positive Identification Panel, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
LQL
Device name
Gram Positive 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
11
Ingested recalls
7

Clearances, product code LQL

By decision year
11 clearances under product code LQL with a decision year between 1986 and 1998, 1991 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LQL by decision year
YearClearances
19861
19881
19891
19901
19912
19931
19961
19972
19981

Applicants with the most clearances

Product code LQL
Applicants holding the most 510(k) clearances under product code LQL
ApplicantClearances
Biomerieux Vitek, Inc.2
Accumed Intl., Inc.1
American Micro Scan1
Analytical Products, Inc.1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Becton Dickinson Microbiology Systems1
Dms Products, Inc.1
Kev Connecticut Diagnostics, Inc.1
Mct Medical, Inc.1
Vitek Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code