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

    CARESIDE AMYLASE

    K Number: K990025 · Decision Feb 8, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    22
    Review Days
    35

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    Basic Information

    Device Name
    CARESIDE AMYLASE
    K Number
    K990025
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Careside, Inc.
    Date Received
    January 4, 1999
    Decision Date
    February 8, 1999
    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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    Other Clearances by Careside, Inc.

    K Number Device Name
    K020484 CARESIDE LDH
    K020486 CARESIDE GGT
    K020487 CARESIDE ALT
    K020488 CARESIDE TRGLYCERIDE
    K002792 CARESIDE CHOLINESTERASE
    K001462 CARESIDE HEMOGLOBIN
    K993771 CARESIDE DIRECT BILIRUBIN
    K993634 CARESIDE ANALYZER
    K992475 CARESIDE CO2, TOTAL
    K991717 CARESIDE MG
    Search all 22 clearances from Careside, Inc. →