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

    LIQUIZYME CHLORIDE REAGENT

    K Number: K820411 · Decision Mar 8, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    18
    Applicant Total
    56
    Review Days
    24

    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 CHLORIDE REAGENT
    K Number
    K820411
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    American Research Products Co.
    Date Received
    February 12, 1982
    Decision Date
    March 8, 1982
    Product Code
    JFS
    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
    JFS Coulometric, Chloride

    Similar 510(k) Clearances

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

    CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    REDI-CHECK PHOTMETER Q.A.

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CHLORIDE REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    REAGENTS CORNING CHLORIDE METER FOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RERMCO TEST CHLORIDE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CHLORIDE REAGENT KIT

    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. →