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

    GENCHEM ISE ELECTROLYTE REFERENCE

    K Number: K040971 · Decision Dec 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    161
    Applicant Total
    8
    Review Days
    252

    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
    GENCHEM ISE ELECTROLYTE REFERENCE
    K Number
    K040971
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1665
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genchem, Inc.
    Date Received
    April 14, 2004
    Decision Date
    December 22, 2004
    Product Code
    JGS
    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
    JGS Electrode, Ion Specific, Sodium

    Similar 510(k) Clearances

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

    ABL90 FLEX PLUS System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    i-STAT CG8+ cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    A-LYTE® Integrated Multisensor (IMT Na K Cl)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GLP systems Track

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Stat Profile Prime Plus Analyzer System

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

    Other Clearances by Genchem, Inc.

    K Number Device Name
    K090283 CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
    K040973 BUN REAGENT
    K040977 GENCHEM ELECTROLYTE BUFFER
    K040975 GENCHEM CO2 ACID REAGENT
    K040976 GENCHEM CREATININE REAGENT
    K040972 CALCIUM, AZO DYE REAGENT
    K040974 GLUCOSE OXIDASE, GLUCOSE