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

    AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT

    K Number: K855034 · Decision Mar 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    35
    Review Days
    84

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    Basic Information

    Device Name
    AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT
    K Number
    K855034
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.4400
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    Bartels Immunodiagnostic Supplies, Inc.
    Date Received
    December 17, 1985
    Decision Date
    March 11, 1986
    Product Code
    LIJ
    Advisory Committee
    Pathology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LIJ Peroxidase Anti-Peroxidase Immunohistochemical Stain

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    Other Clearances by Bartels Immunodiagnostic Supplies, Inc.

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    K860279 CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT
    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. →