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

    REDI-CHECK PHOTMETER Q.A.

    K Number: K923598 · Decision Oct 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    18
    Applicant Total
    18
    Review Days
    86

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    Basic Information

    Device Name
    REDI-CHECK PHOTMETER Q.A.
    K Number
    K923598
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Awareness Technology, Inc.
    Date Received
    July 20, 1992
    Decision Date
    October 14, 1992
    Product Code
    JFS
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JFS Coulometric, Chloride

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