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

    SODIUM & POTASSIUM PRODUCTS

    K Number: K813127 · Decision Jan 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    301
    Applicant Total
    31
    Review Days
    78

    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
    SODIUM & POTASSIUM PRODUCTS
    K Number
    K813127
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Alko Diagnostic Corp.
    Date Received
    November 5, 1981
    Decision Date
    January 22, 1982
    Product Code
    JIX
    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
    JIX Calibrator, Multi-Analyte Mixture

    Similar 510(k) Clearances

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

    VITROS Chemistry Products Calibrator Kit 3

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYSTEM CALIBRATER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN

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

    Other Clearances by Alko Diagnostic Corp.

    K Number Device Name
    K001484 CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838
    K982501 ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44
    K972004 ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS
    K970921 STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)
    K962864 THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS
    K963734 ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS
    K960085 ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS
    K955154 CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT
    K951071 ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS
    K950902 ALKO TONOMETERED SALINE CONTROL
    Search all 31 clearances from Alko Diagnostic Corp. →