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

    DEMAND ACID PHOSPHATASE REAGENT

    K Number: K853949 · Decision Oct 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    19
    Review Days
    22

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    Basic Information

    Device Name
    DEMAND ACID PHOSPHATASE REAGENT
    K Number
    K853949
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Cooper Biomedical, Inc.
    Date Received
    September 24, 1985
    Decision Date
    October 16, 1985
    Product Code
    CKB
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CKB Acid Phosphatase, Naphthyl Phosphate

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    Other Clearances by Cooper Biomedical, Inc.

    K Number Device Name
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    K863301 DEMAND TOTAL PROTEIN
    K861926 WORTHINGTON HDL PRECIPITATING REAGENT SET
    K854130 DEMAND ETHYL ALCOHOL
    K852262 ASSIST CLINICAL CHEMISTRY ANALYZER
    K851285 RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI
    K851284 RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM
    K851286 RADIAL IMMUNODIFFUSION PLATES C3 & C4
    K851282 RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI
    Search all 19 clearances from Cooper Biomedical, Inc. →