BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    BD MAX Check-Points CPO

    K Number: K190613 · Decision Aug 29, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    171

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    Basic Information

    Device Name
    BD MAX Check-Points CPO
    K Number
    K190613
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Check-Points Health B.V.
    Date Received
    March 11, 2019
    Decision Date
    August 29, 2019
    Product Code
    POC
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    POC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

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