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

    CHALLENGE TEST PACK

    K Number: K983451 · Decision Apr 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    264
    Applicant Total
    6
    Review Days
    205

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    Basic Information

    Device Name
    CHALLENGE TEST PACK
    K Number
    K983451
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    North American Science Assoc., Inc.
    Date Received
    September 30, 1998
    Decision Date
    April 23, 1999
    Product Code
    JOJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOJ Indicator, Physical/Chemical Sterilization Process

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    Other Clearances by North American Science Assoc., Inc.

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    K113221 NAMSA BIOLOGICAL INDICATOR SPORE STRIPS
    K113302 NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS
    K962649 SPORTROL RAPID STERILITY INDICATOR