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GMT — Antigens, Ha, Treponema Pallidum Class II

FDA Device Classification

Classification Details

Product Code
GMT
Device Class
Class II
Regulation Number
866.3830
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K971502scimedx tekfile servicesSERODIA TP-PANovember 13, 1997
K911640olympusOLYMPUS PK TP(TM) SYSTEM, MODIFICATIONJuly 24, 1991
K911266olympusMODIFIED PK TP CONTROLMay 7, 1991
K905038fujirebio americaOLYMPUS PK-TP ABSORBENT KITMay 6, 1991
K896410behring diagnosticsCELLOGNOST SYPHILIS HMay 15, 1990
K893124fujirebio diagnosticsOLYMPUS PK(TM) TPNovember 17, 1989
K791897difco laboratoriesBACTO-HATTSNovember 13, 1979
K791457volu sol medical industriesAGGLUTINOTEST-SYPHILISSeptember 24, 1979
K760098gamma biologicalsREAGENT, VDRLAugust 3, 1976