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

    PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT

    K Number: K912231 · Decision Jul 8, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    26
    Applicant Total
    27
    Review Days
    49

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT
    K Number
    K912231
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intl. Immunoassay Laboratories, Inc.
    Date Received
    May 20, 1991
    Decision Date
    July 8, 1991
    Product Code
    JHW
    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
    JHW U.V. Method, Cpk Isoenzymes

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JHW), ordered by most recent decision date.

    Creatine Kinase-MB

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELITECH CLINICAL SYSTEMS CK NAC SL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ROCHE DIAGNOSTICS CK-MB

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELECSYS CK-MB

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Intl. Immunoassay Laboratories, Inc.

    K Number Device Name
    K913380 MYDAS(TM)-MB2/MYDAS(TM)-MB
    K913349 STAMBI-CK
    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)
    K883223 CHECK-MM
    Search all 27 clearances from Intl. Immunoassay Laboratories, Inc. →