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

    PMK PRIMARY MONKEY KIDNEY-CELLS

    K Number: K842833 · Decision Aug 28, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    35
    Review Days
    39

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    Basic Information

    Device Name
    PMK PRIMARY MONKEY KIDNEY-CELLS
    K Number
    K842833
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Bartels Immunodiagnostic Supplies, Inc.
    Date Received
    July 20, 1984
    Decision Date
    August 28, 1984
    Product Code
    KJR
    Advisory Committee
    Hematology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KJR Erythrosin B

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    Other Clearances by Bartels Immunodiagnostic Supplies, Inc.

    K Number Device Name
    K864776 A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS
    K861172 ROTAVIRUS LATEX AGGLUTINATION ASSAY
    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
    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. →