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

    LIQUIZYME NA+/K+ REAGENT SET

    K Number: K820395 · Decision Mar 11, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    161
    Applicant Total
    56
    Review Days
    28

    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
    LIQUIZYME NA+/K+ REAGENT SET
    K Number
    K820395
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1665
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    American Research Products Co.
    Date Received
    February 11, 1982
    Decision Date
    March 11, 1982
    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 American Research Products Co.

    K Number Device Name
    K942984 BUN REAGENT
    K901527 BIURET (COLORMETRIC), TOTAL PROTEIN
    K901960 IRON REAGENTS PRODUCT CODES 7725 AND 7726
    K901964 PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463
    K900827 COLORIMETRIC CHLORIDE PRODUCT #4314125
    K901702 NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522
    K900667 AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711
    K900666 AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791
    K900571 AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)
    K900977 AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500
    Search all 56 clearances from American Research Products Co. →