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

    ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082

    K Number: K823756 · Decision Jan 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    98
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082
    K Number
    K823756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1145
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Em Industries, Inc.
    Date Received
    December 14, 1982
    Decision Date
    January 12, 1983
    Product Code
    CIC
    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
    CIC Cresolphthalein Complexone, Calcium

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    Other Clearances by Em Industries, Inc.

    K Number Device Name
    K832314 CARDIZYME PLUS LD #65094/93