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

    VITALAB AMYLASE REAGENT

    K Number: K040534 · Decision Mar 11, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    36
    Review Days
    9

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    Basic Information

    Device Name
    VITALAB AMYLASE REAGENT
    K Number
    K040534
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clinical Data, Inc.
    Date Received
    March 2, 2004
    Decision Date
    March 11, 2004
    Product Code
    JFJ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    Y

    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 Clinical Data, Inc.

    K Number Device Name
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    K052591 NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
    K033983 VITALAB IRON REAGENT
    K040631 VITALAB DIRECT BILIRUBIN REAGENT
    K034000 VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR
    K040508 VITALAB MAGNESIUM REAGENT
    K040467 VITALAB URIC ACID REAGENT
    K031042 ATAC HEMOGLOBIN A1C REAGENT KIT
    K031044 ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
    K863904 DISPOSABLE ECG MONITORING ELECTRODE
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