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

    HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO

    K Number: K921745 · Decision Jul 30, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    44
    Applicant Total
    63
    Review Days
    108

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    Basic Information

    Device Name
    HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO
    K Number
    K921745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hybritech, Inc.
    Date Received
    April 13, 1992
    Decision Date
    July 30, 1992
    Product Code
    JFH
    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
    JFH Acid Phosphatase (Prostatic), Tartrate Inhibited

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