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

    AMYLASE PRODUCTS

    K Number: K850798 · Decision Mar 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    111
    Review Days
    15

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    Basic Information

    Device Name
    AMYLASE PRODUCTS
    K Number
    K850798
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Data Medical Associates, Inc.
    Date Received
    February 27, 1985
    Decision Date
    March 14, 1985
    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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    K955302 SERUM BICARBONATE/CARBON DIOXIDE
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    K955300 TOTAL BILIRUBIN PROCEDURE
    K952437 DMA GLUCOSE HEXOKINASE U.V. PROCEDURE
    K946161 DMA TOTAL CHOLESTEROL PROCEDURE
    K946354 DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE
    K946355 DMA ALBUMIN PROCEDURE
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