BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

    K Number: K221869 · Decision Sep 5, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    434

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    Basic Information

    Device Name
    BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
    K Number
    K221869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6060
    Medical Specialty
    Medical Genetics
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suzhou Sniper Medical Technologies Co., Ltd.
    Date Received
    June 28, 2022
    Decision Date
    September 5, 2023
    Product Code
    OYX
    Advisory Committee
    Medical Genetics
    Review Advisory Committee
    MG
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OYX Bcr/Abl1 Monitoring Test

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