BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    Blood Transfer Accessory (BTA)

    K Number: K181743 · Decision Jul 30, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    5
    Review Days
    393

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    Basic Information

    Device Name
    Blood Transfer Accessory (BTA)
    K Number
    K181743
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nsp Tech Pte, Ltd.
    Date Received
    July 2, 2018
    Decision Date
    July 30, 2019
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Nsp Tech Pte, Ltd.

    K Number Device Name
    K221783 SafetiCET Safety Lancet
    K221604 SafetiHeel, MediHeel, Novaplus
    K193074 Bevel Up Holder
    K181754 Blood Collection Accessory (BUCA)