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

    BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.

    K Number: K801795 · Decision Sep 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    161
    Applicant Total
    54
    Review Days
    49

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    Basic Information

    Device Name
    BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.
    K Number
    K801795
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1665
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    J.T. Baker Chemical Co.
    Date Received
    July 29, 1980
    Decision Date
    September 16, 1980
    Product Code
    JGS
    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
    JGS Electrode, Ion Specific, Sodium

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    K801669 J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO
    K801661 J.T. BAKER CERULOPLASMIN NEPHELOMETRIC
    K801362 ALBUMIN NEPHELOMETRIC ASSAY
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    K801434 J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS
    Search all 54 clearances from J.T. Baker Chemical Co. →