BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER

    K Number: K872302 · Decision Sep 8, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    207
    Applicant Total
    125
    Review Days
    85

    Basic Information

    Device Name
    MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER
    K Number
    K872302
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    CIBA CORNING DIAGNOSTICS CORP.
    Date Received
    June 15, 1987
    Decision Date
    September 8, 1987
    Product Code
    JJE
    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
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

    Similar 510(k) Clearances

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

    Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION EXL WITH LM SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by CIBA CORNING DIAGNOSTICS CORP.

    K Number Device Name
    K962559 ACS CORTISOL IMMUNOASSAY
    K963251 CIBA CORNING ACS;180 DPD ASSAY
    K961807 CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
    K961657 CIBA CORNING 400 SYSTEM
    K962021 CIBA CORNING 348 SYSTEM
    K962126 ACS CKMB II IMMUNOASSAY
    K962041 ACS LH2 IMMUNOASSAY
    K961510 ACS FRT4 IMMUNOASSAY
    K960246 LIQUID CARDIAC MARKER 1,2,3 ASSAYED
    K955873 ACS PHENYTOIN ASSAY
    Search all 125 clearances from CIBA CORNING DIAGNOSTICS CORP. →