BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CK/LD ISOENZYME CONTROL PROD. #ACS CT101

    K Number: K800370 · Decision Mar 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    42
    Review Days
    21

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    Basic Information

    Device Name
    CK/LD ISOENZYME CONTROL PROD. #ACS CT101
    K Number
    K800370
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Analytical Control Systems, Inc.
    Date Received
    February 20, 1980
    Decision Date
    March 12, 1980
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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