BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT

    K Number: K860279 · Decision May 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    16
    Applicant Total
    35
    Review Days
    119

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    Basic Information

    Device Name
    CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT
    K Number
    K860279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Bartels Immunodiagnostic Supplies, Inc.
    Date Received
    January 14, 1986
    Decision Date
    May 13, 1986
    Product Code
    LIN
    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
    LIN Antisera, Conjugated Fluorescent, Cytomegalovirus

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    K855034 AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT
    K842830 IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF
    K852185 RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT
    K844105 FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY
    K842834 HEP-2 CELLS
    K842833 PMK PRIMARY MONKEY KIDNEY-CELLS
    K842328 AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN
    K842329 AMER. HISTO-ID SYS PRIMARY IGG S7920-11
    Search all 35 clearances from Bartels Immunodiagnostic Supplies, Inc. →