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

    CHEM PRO 1000 CHEMISTRY ANALYSIS

    K Number: K851100 · Decision Jul 9, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    88
    Applicant Total
    5
    Review Days
    112

    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
    CHEM PRO 1000 CHEMISTRY ANALYSIS
    K Number
    K851100
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1600
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sen Tech Medical Corp.
    Date Received
    March 19, 1985
    Decision Date
    July 9, 1985
    Product Code
    CEM
    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
    CEM Electrode, Ion Specific, Potassium

    Similar 510(k) Clearances

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

    ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ABL90 FLEX PLUS System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EasyStat 300

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ISE Electrodes

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FLEXLAB 3.6, ACCELERATOR A3600

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

    Other Clearances by Sen Tech Medical Corp.

    K Number Device Name
    K910071 PORTA GAS COMPRESSED GAS CYLINDER CART
    K855091 CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS
    K854260 CHEMPRO 1000
    K841575 SENTECH'S ULAB 1000 CLINICAL CHEM.