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

    STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715

    K Number: K870746 · Decision Jun 1, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    47
    Review Days
    96

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    Basic Information

    Device Name
    STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715
    K Number
    K870746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Stanbio Laboratory
    Date Received
    February 25, 1987
    Decision Date
    June 1, 1987
    Product Code
    JFJ
    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
    JFJ Catalytic Methods, Amylase

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    SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607

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    K050266 DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
    K050283 CREATININE LIQUICOLOR
    K042169 STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER
    K041155 WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
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    K032932 DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR
    K032482 STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
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