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

    SPQ(TM) ANTIBODY REAGENT SET II FOR AAT

    K Number: K890415 · Decision Feb 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    29
    Applicant Total
    18
    Review Days
    24

    Basic Information

    Device Name
    SPQ(TM) ANTIBODY REAGENT SET II FOR AAT
    K Number
    K890415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5130
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    ATLANTIC ANTIBODIES
    Date Received
    January 24, 1989
    Decision Date
    February 17, 1989
    Product Code
    DEM
    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
    DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control

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    Other Clearances by ATLANTIC ANTIBODIES

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    K890563 SPQ(TM) ANTIBODY REAGENT SET II FOR TRF
    K890561 SPQ(TM) ANTIBODY REAGENT SET II FOR IGM
    K890416 SPQ(TM) ANTIBODY REAGENT SET II FOR IGG
    K890562 SPQ(TM) ANTIBODY REAGENT SET II FOR HPT
    K890564 SPQ(TM) ANTIBODY REAGENT SET II FOR C4
    K890417 SPQ(TM) ANTIBODY REAGENT SET II FOR C3
    K890560 SPQ(TM) ANTIBODY REAGENT SET II FOR IGA
    K884297 SPQ(TM) TEST SYSTEM FOR PREALBUMIN
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