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

    J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

    K Number: K801661 · Decision Sep 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    54
    Review Days
    57

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    Basic Information

    Device Name
    J.T. BAKER CERULOPLASMIN NEPHELOMETRIC
    K Number
    K801661
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5210
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    J.T. Baker Chemical Co.
    Date Received
    July 21, 1980
    Decision Date
    September 16, 1980
    Product Code
    DDB
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DDB Ceruloplasmin, Antigen, Antiserum, Control

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    Other Clearances by J.T. Baker Chemical Co.

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    K802035 BAKER DIAG. ULTRARATE CO2 REAGENT KIT
    K801909 LSA 290 ASSAY REAGENTS/NEPHELOMETRIC
    K801662 J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.
    K801669 J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO
    K801795 BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.
    K801362 ALBUMIN NEPHELOMETRIC ASSAY
    K801432 HEMOPEXIN NEPHELOMETRIC ASSAY
    K801434 J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS
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