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

    BAKER DIAG. ULTRARATE CO2 REAGENT KIT

    K Number: K802035 · Decision Sep 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    27
    Applicant Total
    54
    Review Days
    35

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    Basic Information

    Device Name
    BAKER DIAG. ULTRARATE CO2 REAGENT KIT
    K Number
    K802035
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    J.T. Baker Chemical Co.
    Date Received
    August 22, 1980
    Decision Date
    September 26, 1980
    Product Code
    JFL
    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
    JFL Ph Rate Measurement, Carbon-Dioxide

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    Other Clearances by J.T. Baker Chemical Co.

    K Number Device Name
    K803128 SERIES 810 PLATELET ANALYZER
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    K801662 J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.
    K801669 J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO
    K801661 J.T. BAKER CERULOPLASMIN NEPHELOMETRIC
    K801795 BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.
    K801362 ALBUMIN NEPHELOMETRIC ASSAY
    K801432 HEMOPEXIN NEPHELOMETRIC ASSAY
    K801434 J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS
    Search all 54 clearances from J.T. Baker Chemical Co. →