GMJ · Class II · 21 CFR 866.3320

FDA Product Code GMJ: Antigens, Histoplasma Capsulatum, All

Leading manufacturers include Immuno-Mycologics, Inc., 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 May 05, 1983
LA-HISTO ANTIBODY SYSTEM #HL 1001
K830837
Immuno-Mycologics, Inc.
Microbiology · 50d
Cleared Dec 31, 1981
MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL
K813359
American Scientific Products
Microbiology · 31d
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 Aug 16, 1979
FUNGAL IMMUNODIFFUSION KIT #ID1001
K791384
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
HISTOPLASMA YEAST ANTI #CF10021X
K791393
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
HISTOPLASMA MYCELIAL #CF10020X
K791394
Immuno-Mycologics, Inc.
Microbiology · 36d
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