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

    SERUM BICARBONATE/CARBON DIOXIDE

    K Number: K955302 · Decision Feb 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    85
    Applicant Total
    111
    Review Days
    101

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    Basic Information

    Device Name
    SERUM BICARBONATE/CARBON DIOXIDE
    K Number
    K955302
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Data Medical Associates, Inc.
    Date Received
    November 20, 1995
    Decision Date
    February 29, 1996
    Product Code
    KHS
    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
    KHS Enzymatic, Carbon-Dioxide

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    K955300 TOTAL BILIRUBIN PROCEDURE
    K952437 DMA GLUCOSE HEXOKINASE U.V. PROCEDURE
    K946161 DMA TOTAL CHOLESTEROL PROCEDURE
    K946354 DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE
    K946355 DMA ALBUMIN PROCEDURE
    K944255 DMA CALCIUM PLUS PROCEDURE
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