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

    QUALITROL SYPHSERO CONTROL SET

    K Number: K961998 · Decision Aug 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    8
    Applicant Total
    20
    Review Days
    78

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    Basic Information

    Device Name
    QUALITROL SYPHSERO CONTROL SET
    K Number
    K961998
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3820
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Consolidated Technologies, Inc.
    Date Received
    May 22, 1996
    Decision Date
    August 8, 1996
    Product Code
    GMP
    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
    GMP Antisera, Control For Nontreponemal Tests

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