GMI · Class II · 21 CFR 866.3135

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

Leading manufacturers include Meridian Diagnostics, Inc. and I M, Inc..

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 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 Mar 17, 1978
CANDIDA IMMUNODIFFUSION KIT
K770527
I M, Inc.
Microbiology · 364d

About Product Code GMI - Regulatory Context