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

    SAS FRANCISELLA TULARENSIS ANTISERUM

    K Number: K952141 · Decision Jul 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    199
    Review Days
    74

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    Basic Information

    Device Name
    SAS FRANCISELLA TULARENSIS ANTISERUM
    K Number
    K952141
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3280
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sa Scientific, Inc.
    Date Received
    May 8, 1995
    Decision Date
    July 21, 1995
    Product Code
    GSK
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GSK Antiserum, Francisella Tularensis

    Other Clearances by Sa Scientific, Inc.

    K Number Device Name
    K100227 SAS FLUALERT A&B, SAS INFLUENZA A TEST
    K080380 SAS INFLUENZA A & B TEST
    K041439 SAS INFLUENZA B TEST
    K041441 SAS INFLUENZA A TEST
    K030628 SAS RSV CONTROL KIT
    K022845 SAS RSV TEST
    K022683 SAS BLOOD/SERUM/URINE/URINE HCG
    K023270 SAS STREPALERT
    K020438 SAS VALUE HCG
    K013379 SAS STREPALERT
    Search all 199 clearances from Sa Scientific, Inc. →