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

    AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 &

    K Number: K853888 · Decision Oct 15, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    158
    Applicant Total
    56
    Review Days
    26

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    Basic Information

    Device Name
    AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 &
    K Number
    K853888
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    American Research Products Co.
    Date Received
    September 19, 1985
    Decision Date
    October 15, 1985
    Product Code
    CGX
    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
    CGX Alkaline Picrate, Colorimetry, Creatinine

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    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. →