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

Antigen, Latex Agglutination, Coccidioides Immitis

21 CFR 866.3135 / Microbiology
FDA source (opens on fda.gov)

GMG is the FDA product code for Antigen, Latex Agglutination, Coccidioides Immitis, a class II device type, regulated under 21 CFR 866.3135. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GMG
Device name
Antigen, Latex Agglutination, Coccidioides Immitis
Regulation
21 CFR 866.3135
Device class
Class II
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
5
Ingested recalls
0

Clearances, product code GMG

By decision year
5 clearances under product code GMG with a decision year between 1976 and 1981, 1979 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GMG by decision year
YearClearances
19761
19792
19801
19811

Applicants with the most clearances

Product code GMG
Applicants holding the most 510(k) clearances under product code GMG
ApplicantClearances
I M, Inc.2
American Scientific Products1
IMMY, Inc.1
Meridian Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code