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

    CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02

    K Number: K991109 · Decision May 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    158
    Applicant Total
    18
    Review Days
    54

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    Basic Information

    Device Name
    CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02
    K Number
    K991109
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    A.P. Total Care, Inc.
    Date Received
    April 1, 1999
    Decision Date
    May 25, 1999
    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 A.P. Total Care, Inc.

    K Number Device Name
    K991246 FRUCTOSAMINE, MODEL FR 106-01
    K991762 ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02
    K991761 MAGNESIUM PRODUCT NO'S, 112-01, 112-02
    K991664 LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
    K991665 HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
    K991867 INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
    K991866 BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
    K991870 ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
    K991663 AST/SGOT
    K991666 TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
    Search all 18 clearances from A.P. Total Care, Inc. →