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

    SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST

    K Number: K844582 · Decision Jan 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    34
    Applicant Total
    31
    Review Days
    54

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    Basic Information

    Device Name
    SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST
    K Number
    K844582
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Syncor Intl. Corp.
    Date Received
    November 23, 1984
    Decision Date
    January 16, 1985
    Product Code
    LJP
    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
    LJP Antiserum, Fluorescent, Chlamydia Trachomatis

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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
    K852665 SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY
    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
    Search all 31 clearances from Syncor Intl. Corp. →