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

    J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY

    K Number: K801283 · Decision Jun 30, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    53
    Applicant Total
    54
    Review Days
    32

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    Basic Information

    Device Name
    J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY
    K Number
    K801283
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    J.T. Baker Chemical Co.
    Date Received
    May 29, 1980
    Decision Date
    June 30, 1980
    Product Code
    CZP
    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
    CZP Iga, Antigen, Antiserum, Control

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    K801909 LSA 290 ASSAY REAGENTS/NEPHELOMETRIC
    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
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