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

    BUN, MODEL BU 104-01

    K Number: K990980 · Decision May 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    116
    Applicant Total
    18
    Review Days
    63

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    Basic Information

    Device Name
    BUN, MODEL BU 104-01
    K Number
    K990980
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    A.P. Total Care, Inc.
    Date Received
    March 23, 1999
    Decision Date
    May 25, 1999
    Product Code
    CDQ
    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
    CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

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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. →