GMI · Class II · 21 CFR 866.3135

FDA Product Code GMI: Antigen, Cf And / Or Id, Coccidioides Immitis

Leading manufacturers include Meridian Diagnostics, Inc., Immuno-Mycologics, Inc. and American Scientific Products.

11
Total
11
Cleared
67d
Avg days
1978
Since

FDA 510(k) Cleared Antigen, Cf And / Or Id, Coccidioides Immitis Devices (Product Code GMI)

11 devices
1–11 of 11
Cleared Oct 31, 1989
OLYMPUS PK-TP SYSTEM REACTIVE CONTROL
K894617
Schiff & Co.
Microbiology · 103d
Cleared Aug 31, 1981
COCCIDIOIDES IMMUNODIFFUSION SYSTEM
K812190
American Scientific Products
Microbiology · 28d
Cleared Aug 25, 1981
FUNGAL IMMUNODIFFUSION SYSTEM
K812185
American Scientific Products
Microbiology · 22d
Cleared Sep 26, 1980
IMMUNODIFFUSION REAGENTS/SEROLOGICAL
K802129
Nolan Biological Laboratories, Inc.
Microbiology · 53d
Cleared Jan 24, 1980
CANDIDA ALBICANS, ANTIGEN
K792716
Meridian Diagnostics, Inc.
Microbiology · 28d
Cleared Jan 23, 1980
CANDIDA ALBICANS, ANTISERUM
K792713
Meridian Diagnostics, Inc.
Microbiology · 27d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTIGEN
K792682
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTIGEN
K792689
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Aug 16, 1979
CANDIDA IMMUNODIFFUSION KIT #CA1001
K791383
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
COCCIDIOIDES ANTIGEN #CF10023X
K791389
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Mar 17, 1978
CANDIDA IMMUNODIFFUSION KIT
K770527
I M, Inc.
Microbiology · 364d

About Product Code GMI - Regulatory Context