GMJ · Class II · 21 CFR 866.3320

FDA Product Code GMJ: Antigens, Histoplasma Capsulatum, All

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

12
Total
12
Cleared
31d
Avg days
1976
Since

FDA 510(k) Cleared Antigens, Histoplasma Capsulatum, All Devices (Product Code GMJ)

12 devices
1–12 of 12
Cleared Jan 23, 1980
HISTOPLASMA CAPSULATUM, ANTIGEN
K792701
Meridian Diagnostics, Inc.
Microbiology · 27d
Cleared Jan 17, 1980
HISTOPLASMA CAPSULATUM, ANTIGEN YEAST
K792704
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
HISTOPLASMA CAPSULATUM, MYCELIAL PHASE
K792708
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
HISTOPLASMA CAPSULATUM, ANTISERUM
K792711
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Nov 01, 1976
HISTOPLASMA MYCELIAL ANTIGEN
K760826
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
HISTOPLASMA YEAST ANTIGEN
K760827
I M, Inc.
Immunology · 19d

About Product Code GMJ - Regulatory Context