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

    REAGENTS FOR DETERM. CO2 IN HUMAN SERUM

    K Number: K800681 · Decision May 30, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    26
    Review Days
    65

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    Basic Information

    Device Name
    REAGENTS FOR DETERM. CO2 IN HUMAN SERUM
    K Number
    K800681
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Solutions, Inc.
    Date Received
    March 26, 1980
    Decision Date
    May 30, 1980
    Product Code
    KMS
    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
    KMS Phenolphthalein Colorimetry, Carbon-Dioxide

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    Other Clearances by Diagnostic Solutions, Inc.

    K Number Device Name
    K934892 RELIEF PLUS ONE REAGENT STRIP MODIFICATION
    K924398 UNI-CHECK REAGENT STRIP
    K921825 QUICK-CHECK II REAGENT STRIP
    K800689 REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-
    K800672 SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
    K800674 SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER
    K800687 REAGENT FOR DETERM. GLUCOSE IN H/SERUM
    K800679 REAGENTS FOR DETERM. ALKALINE PHOSPHATAS
    K800685 REAGENT FOR DETERM. CREATININE IN H/SERU
    K800692 REAGENT FOR DETERM. POTASSIUM/IN HUMAN
    Search all 26 clearances from Diagnostic Solutions, Inc. →