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

    ESKLAB REAGENT TABLETS

    K Number: K790918 · Decision Jun 22, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    42
    Review Days
    39

    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
    ESKLAB REAGENT TABLETS
    K Number
    K790918
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Smithkline Diagnostics, Inc.
    Date Received
    May 14, 1979
    Decision Date
    June 22, 1979
    Product Code
    JHS
    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
    JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes

    Similar 510(k) Clearances

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

    Creatine Kinase

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CKMB UDR ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    S40 CREATINE KINASE (CK)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARESIDE CK

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARESIDE CKMB

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

    Other Clearances by Smithkline Diagnostics, Inc.

    K Number Device Name
    K961062 FLEXSURE OBT
    K960183 FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
    K934863 FLEXSURE HP
    K880499 HEMOCCULT SENSITIVE TEST
    K875131 (SKD) CHOLESTEROL TEST KIT
    K862849 HEMOCCULT WIPE TEST
    K854723 SKD ELECTROCHEMICAL SYSTEM (ECS)
    K852841 RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
    K821884 GASTROCCULT TM
    K821674 SPINCHEM ACID PHOSPHATASE REAGENT
    Search all 42 clearances from Smithkline Diagnostics, Inc. →