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

    PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL

    K Number: K111363 · Decision Dec 6, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    21
    Applicant Total
    47
    Review Days
    204

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    Basic Information

    Device Name
    PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL
    K Number
    K111363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3700
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medica Corp.
    Date Received
    May 16, 2011
    Decision Date
    December 6, 2011
    Product Code
    JXN
    Advisory Committee
    Clinical Toxicology
    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
    JXN Enzyme Immunoassay, Propoxyphene

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