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

    POLYMEDCO OC AUTO MICRO 80 FOB TEST

    K Number: K041408 · Decision Oct 21, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    5
    Applicant Total
    19
    Review Days
    147

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    Basic Information

    Device Name
    POLYMEDCO OC AUTO MICRO 80 FOB TEST
    K Number
    K041408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Polymedco, Inc.
    Date Received
    May 27, 2004
    Decision Date
    October 21, 2004
    Product Code
    OOX
    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
    OOX Automated Occult Blood Analyzer

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    Other Clearances by Polymedco, Inc.

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    K041297 POLYMEDCO OC LIGHT FOBT TEST
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