GMH · Class II · 21 CFR 866.3135

FDA Product Code GMH: Antiserum, Positive Control, Coccidioides Immitis

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

5
Total
5
Cleared
24d
Avg days
1976
Since

FDA 510(k) Cleared Antiserum, Positive Control, Coccidioides Immitis Devices (Product Code GMH)

5 devices
1–5 of 5
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTISERUM,
K792684
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTISERUM
K792688
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTISERUM POS.
K792717
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Nov 01, 1976
ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL)
K760834
I M, Inc.
Immunology · 19d

About Product Code GMH - Regulatory Context