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

    SMAC REPLACEMENT REAGENTS/OF BUN-SERUM

    K Number: K800673 · Decision May 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    20
    Applicant Total
    26
    Review Days
    63

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    Basic Information

    Device Name
    SMAC REPLACEMENT REAGENTS/OF BUN-SERUM
    K Number
    K800673
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Solutions, Inc.
    Date Received
    March 26, 1980
    Decision Date
    May 28, 1980
    Product Code
    CDW
    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
    CDW Diacetyl-Monoxime, Urea Nitrogen

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    Other Clearances by Diagnostic Solutions, Inc.

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    K800681 REAGENTS FOR DETERM. CO2 IN HUMAN SERUM
    K800672 SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
    K800674 SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER
    K800687 REAGENT FOR DETERM. GLUCOSE IN H/SERUM
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    K800685 REAGENT FOR DETERM. CREATININE IN H/SERU
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