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

    LAS-R TM

    K Number: K771780 · Decision Oct 4, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    44
    Review Days
    11

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    Basic Information

    Device Name
    LAS-R TM
    K Number
    K771780
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5620
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Hyland Therapeutic Div., Travenol Laboratories
    Date Received
    September 23, 1977
    Decision Date
    October 4, 1977
    Product Code
    DEB
    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
    DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control

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    Other Clearances by Hyland Therapeutic Div., Travenol Laboratories

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    K812220 NEPHELOMETRIC SOLID TURBIDITY STANDARD
    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
    Search all 44 clearances from Hyland Therapeutic Div., Travenol Laboratories →