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JWZ — Kit, Screening, Trichomonas Class I

FDA Device Classification

Classification Details

Product Code
JWZ
Device Class
Class I
Regulation Number
866.2660
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K033864genzymeGENZYME OSOM TRICHOMONAS RAPID TESTApril 2, 2004
K020595xenotope diagnosticsXENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01February 20, 2003
K020226hellen professional servicesXENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02August 22, 2002
K894246meridian diagnosticsMERIVIEW TM TRICHOMONASAugust 15, 1989
K892802mercia diagnosticsSUPER DUOJune 13, 1989
K892263meridian diagnosticsMERIFLUOR(TM) -TRICHOMONASMay 24, 1989
K875138mercia diagnosticsTRICHOMATE(R) SUPERMay 13, 1988
K874259california integrated diagnosticsTRICHOMONAS DIRECT ENZYME IMMUNOASSAYDecember 7, 1987
K871279california integrated diagnosticsMODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KITApril 8, 1987
K852665syncor intlSYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAYAugust 13, 1985
K830497hedecoPEM-TApril 5, 1983