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GMM — Antigens, Iha, Toxoplasma Gondii Class II

FDA Device Classification

Classification Details

Product Code
GMM
Device Class
Class II
Regulation Number
866.3780
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K981263instrumentation laboratoryTOXOGENAugust 6, 1998
K952818pyramid biologicalENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDIINovember 20, 1995
K851977si sero-immuno diagnosticsHEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KITOctober 16, 1985
K851976si sero-immuno diagnosticsHEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KITOctober 16, 1985
K830870parasitic disease consultantsPOLYCHACO INDIRECT HEMAGGLUTINATIONAugust 12, 1983
K802452syn-kitTOXOTEST-MT EIKEN KITDecember 18, 1980
K790460calbiochem-behringTXOCELL-IHA REAGENT SYSTEMMay 25, 1979
K771560burroughs wellcomeTOXHA TESTSeptember 15, 1977