GMM · Class II · 21 CFR 866.3780

FDA Product Code GMM: Antigens, Iha, Toxoplasma Gondii

Leading manufacturers include Si Sero-Immuno Diagnostics, Inc., Burroughs Wellcome Co. and Calbiochem-Behring Corp..

8
Total
8
Cleared
116d
Avg days
1977
Since

FDA 510(k) Cleared Antigens, Iha, Toxoplasma Gondii Devices (Product Code GMM)

8 devices
1–8 of 8
Cleared Aug 06, 1998
TOXOGEN
K981263
Instrumentation Laboratory CO
Microbiology · 121d
Cleared Nov 20, 1995
ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
K952818
Pyramid Biological Corp.
Microbiology · 153d
Cleared Oct 16, 1985
HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT
K851976
Si Sero-Immuno Diagnostics, Inc.
Microbiology · 162d
Cleared Oct 16, 1985
HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT
K851977
Si Sero-Immuno Diagnostics, Inc.
Microbiology · 162d
Cleared Aug 12, 1983
POLYCHACO INDIRECT HEMAGGLUTINATION
K830870
Parasitic Disease Consultants
Microbiology · 147d
Cleared Dec 18, 1980
TOXOTEST-MT EIKEN KIT
K802452
Syn-Kit, Inc.
Microbiology · 71d
Cleared May 25, 1979
TXOCELL-IHA REAGENT SYSTEM
K790460
Calbiochem-Behring Corp.
Microbiology · 81d
Cleared Sep 15, 1977
TOXHA TEST
K771560
Burroughs Wellcome Co.
Toxicology · 31d

About Product Code GMM - Regulatory Context