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

    RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.

    K Number: K882801 · Decision Aug 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    53

    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
    RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.
    K Number
    K882801
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1665
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hf Scientific, Inc.
    Date Received
    July 7, 1988
    Decision Date
    August 29, 1988
    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 Hf Scientific, Inc.

    K Number Device Name
    K880967 MICRO CO2 APPARATUS
    K874429 HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12
    K864313 CO2 REAGENT SET
    K864862 REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.