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

    Instant-view-PLUS immunochemical Fecal Occult Blood Test

    K Number: K173212 · Decision Feb 15, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    96
    Applicant Total
    1
    Review Days
    136

    Basic Information

    Device Name
    Instant-view-PLUS immunochemical Fecal Occult Blood Test
    K Number
    K173212
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alfa Scientific Designs, Inc.
    Date Received
    October 2, 2017
    Decision Date
    February 15, 2018
    Product Code
    KHE
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KHE Reagent, Occult Blood

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