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

    125I QUICK-MB TEST KIT FOR QUANTITATION

    K Number: K821964 · Decision Jul 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    20
    Applicant Total
    27
    Review Days
    21

    Basic Information

    Device Name
    125I QUICK-MB TEST KIT FOR QUANTITATION
    K Number
    K821964
    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 1, 1982
    Decision Date
    July 22, 1982
    Product Code
    JHT
    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
    JHT Chromatographic Separation, Cpk Isoenzymes

    Similar 510(k) Clearances

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

    SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COULTER CK-MB ISOENZYME REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DSL CK-MB (DSL #3200)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-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
    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
    K883223 CHECK-MM
    Search all 27 clearances from INTL. IMMUNOASSAY LABORATORIES, INC. →