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

    SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M

    K Number: K850586 · Decision Mar 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    10
    Review Days
    29

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    Basic Information

    Device Name
    SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M
    K Number
    K850586
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Applications Lab
    Date Received
    February 13, 1985
    Decision Date
    March 14, 1985
    Product Code
    DAO
    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
    DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control

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    Other Clearances by Applications Lab

    K Number Device Name
    K850587 SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN
    K850588 SPQ TEST SYSTEM FOR COMPLEMENT C3
    K850589 SPQ TEST SYSTEM FOR TRANSFERRIN
    K850603 SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN
    K850584 SPQ TEST SYSTEM FOR HAPTOGLOBIN
    K850590 SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN
    K850583 SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G
    K850582 SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A
    K850585 SPQ TEST SYSTEM FOR COMPLEMENT C4