GMG · Class II · 21 CFR 866.3135

FDA Product Code GMG: Antigen, Latex Agglutination, Coccidioides Immitis

Leading manufacturers include I M, Inc., Immuno-Mycologics, Inc. and Meridian Diagnostics, Inc..

5
Total
5
Cleared
30d
Avg days
1976
Since

FDA 510(k) Cleared Antigen, Latex Agglutination, Coccidioides Immitis Devices (Product Code GMG)

5 devices
1–5 of 5
Cleared Aug 25, 1981
COCCIDIOIDES LATEX AGGLUTINATION
K812189
American Scientific Products
Microbiology · 22d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, LATEX AGGLUTI
K792690
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Aug 16, 1979
COCCIDIODES (COCCI)
K791381
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Feb 01, 1979
REAGENT, COCCI LATEX
K782070
I M, Inc.
Microbiology · 51d
Cleared Nov 01, 1976
COCCIDIOIDES MYCELIAL ANTIGEN
K760829
I M, Inc.
Immunology · 19d

About Product Code GMG - Regulatory Context