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

Antigens, Nontreponemal, All

21 CFR 866.3820 / Microbiology
FDA source (opens on fda.gov)

GMQ is the FDA product code for Antigens, Nontreponemal, All, a class II device type, regulated under 21 CFR 866.3820. As of , FDA records hold 32 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GMQ
Device name
Antigens, Nontreponemal, All
Regulation
21 CFR 866.3820
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
32
Ingested recalls
0

Clearances, product code GMQ

By decision year
32 clearances under product code GMQ with a decision year between 1981 and 2025, 1981 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GMQ by decision year
YearClearances
19813
19823
19832
19842
19851
19861
19873
19883
19901
19912
19963
19991
20002
20151
20182
20201
20251

Applicants with the most clearances

Product code GMQ
Applicants holding the most 510(k) clearances under product code GMQ
ApplicantClearances
Arlington Scientific, Inc. (Asi)3
Oxoid U.S.A., Inc.3
Ampcor, Inc.2
EMD Millipore Corporation2
Gold Standard Diagnostics, LLC2
Adi Diagnostics, Inc.1
Advanced Polymer Systems, Inc.1
American Dade1
Avanti Polar Lipids, Inc.1
Beacon Biologicals, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order