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

    BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH

    K Number: K850144 · Decision Jun 17, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    205
    Applicant Total
    36
    Review Days
    154

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    Basic Information

    Device Name
    BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH
    K Number
    K850144
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    American Sterilizer Co.
    Date Received
    January 14, 1985
    Decision Date
    June 17, 1985
    Product Code
    FRC
    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
    FRC Indicator, Biological Sterilization Process

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