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

    ULTRAZYME PLUS AMYL #65031&64982

    K Number: K821459 · Decision May 28, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    62
    Review Days
    10

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    Basic Information

    Device Name
    ULTRAZYME PLUS AMYL #65031&64982
    K Number
    K821459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Emd Chemicals, Inc.
    Date Received
    May 18, 1982
    Decision Date
    May 28, 1982
    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 Emd Chemicals, Inc.

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    K951750 GLUCOSE TEST ITEM NUMBER 97375/94
    K950234 TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2
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