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

    EMBRIA-CK

    K Number: K801728 · Decision Sep 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    47
    Applicant Total
    27
    Review Days
    64

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    Basic Information

    Device Name
    EMBRIA-CK
    K Number
    K801728
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Intl. Immunoassay Laboratories, Inc.
    Date Received
    July 24, 1980
    Decision Date
    September 26, 1980
    Product Code
    JHX
    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
    JHX Fluorometric Method, Cpk Or Isoenzymes

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    Other Clearances by Intl. Immunoassay Laboratories, Inc.

    K Number Device Name
    K913380 MYDAS(TM)-MB2/MYDAS(TM)-MB
    K913349 STAMBI-CK
    K912231 PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT
    K903441 MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
    K903508 LABELLING CHANGES TO IMPRES-MB-X
    K901450 MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB
    K890609 IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)
    K890543 IMPRES-MB REAGENT A AND REAGENT B
    K883432 IMMUNOCCULT-LXI
    K883222 ISOFOR-MM (TM)
    Search all 27 clearances from Intl. Immunoassay Laboratories, Inc. →