BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    I-CHROMA IFOB WITH I-CHROMA READER

    K Number: K132167 · Decision May 2, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    294

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    Basic Information

    Device Name
    I-CHROMA IFOB WITH I-CHROMA READER
    K Number
    K132167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boditech Med, Inc.
    Date Received
    July 12, 2013
    Decision Date
    May 2, 2014
    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 Boditech Med, Inc.

    K Number Device Name
    K170232 AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer