LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K221970
    Device Name
    Lancing device
    Manufacturer
    SteriLance Medical(Suzhou) Inc.
    Date Cleared
    2022-08-30

    (56 days)

    Product Code
    QRL
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    SteriLance Medical(Suzhou) Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lancing device is used with disposable blood lancet to obtain capillary blood samples.
    Device Description
    Lancing device is used with disposable blood lancet to obtain capillary blood samples. It has multiple penetration depth levels, normally 6 or 9. Lancing device is for single patient use only.
    Ask a Question

    Page 1 of 1