BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID

    K Number: K771879 · Decision Oct 19, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    44
    Review Days
    15

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    Basic Information

    Device Name
    GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID
    K Number
    K771879
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5420
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Hyland Therapeutic Div., Travenol Laboratories
    Date Received
    October 4, 1977
    Decision Date
    October 19, 1977
    Product Code
    DEN
    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
    DEN Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control

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    K810078 Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S
    K810077 OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.
    K802610 ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
    K791113 LOW IONIC STRENGTH SOLUTION (LISS)
    K790249 TEST CELLS
    K781225 GLOBULIN TEST, HUMAN THYROXINE BINDING
    K780962 AUTOMATED ENZYME
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