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

    CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-

    K Number: K833447 · Decision May 21, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    9
    Applicant Total
    35
    Review Days
    229

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    Basic Information

    Device Name
    CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-
    K Number
    K833447
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Bartels Immunodiagnostic Supplies, Inc.
    Date Received
    October 5, 1983
    Decision Date
    May 21, 1984
    Product Code
    MCB
    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
    MCB Antigen, C. Difficile

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    Other Clearances by Bartels Immunodiagnostic Supplies, Inc.

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    K860279 CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT
    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
    Search all 35 clearances from Bartels Immunodiagnostic Supplies, Inc. →