BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY

    K Number: K852665 · Decision Aug 13, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    10
    Applicant Total
    31
    Review Days
    50

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    Basic Information

    Device Name
    SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY
    K Number
    K852665
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Syncor Intl. Corp.
    Date Received
    June 24, 1985
    Decision Date
    August 13, 1985
    Product Code
    JWZ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JWZ Kit, Screening, Trichomonas

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    Other Clearances by Syncor Intl. Corp.

    K Number Device Name
    K945825 SECURE SAFETY INSERT
    K851828 IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C
    K850433 CESIUM 137 ENDOMETRIAL SOURCE
    K852023 CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41
    K851033 SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT
    K844735 PTH-RIA
    K850163 IRIDIUM 192 WIRES
    K850208 FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS
    K850726 WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD
    K850434 CS137 SEALED SOURCES
    Search all 31 clearances from Syncor Intl. Corp. →