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

    LAS-R HUMAN C1 ESTERASE INHIBITOR TEST

    K Number: K780335 · Decision Mar 22, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    12
    Applicant Total
    44
    Review Days
    22

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    Basic Information

    Device Name
    LAS-R HUMAN C1 ESTERASE INHIBITOR TEST
    K Number
    K780335
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5250
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Hyland Therapeutic Div., Travenol Laboratories
    Date Received
    February 28, 1978
    Decision Date
    March 22, 1978
    Product Code
    DBA
    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
    DBA Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control

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    K Number Device Name
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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
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