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

    IMMUNOCCULT-LXI

    K Number: K883432 · Decision Oct 31, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    96
    Applicant Total
    27
    Review Days
    77

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    Basic Information

    Device Name
    IMMUNOCCULT-LXI
    K Number
    K883432
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Immunoassay Laboratories, Inc.
    Date Received
    August 15, 1988
    Decision Date
    October 31, 1988
    Product Code
    KHE
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KHE Reagent, Occult Blood

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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
    K883222 ISOFOR-MM (TM)
    K883223 CHECK-MM
    Search all 27 clearances from Intl. Immunoassay Laboratories, Inc. →