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510(k) Data Aggregation

    K Number
    K113513
    Device Name
    PLANCET
    Manufacturer
    MICROPOINT TECHNOLOGIES PTE LTD
    Date Cleared
    2012-07-13

    (228 days)

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

    MICROPOINT TECHNOLOGIES PTE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PLANCET blood lancet is a puncture device to obtain micro-litre capillary whole blood samples from finger tips or palm or alternate body sites. The PLANCET blood lancet is normally loaded in a spring-operated lancing device for rapid puncture of skin.
    Device Description
    The PLANCET blood lancet is a needle device to be loaded in a spring operated lancing device for pricking a patient's finger or palm to draw a micro-litre sample of whole blood to perform in-vitro diagnostic (IVD) blood tests. The PLANCET has a needle that is encapsulated by a plastic material that forms a body and a cap. This plastic encapsulation ensures the needle's integrity and sterility till point of use. The needle is made of a high performance and bio-compatible plastic material. The procedure to use PLANCET is to pull off the cap and to load PLANCET into a spring operated lancing device. Once triggered, the PLANCET will be actuated and retracted rapidly to penetrate the skin and create a small wound for getting some capillary whole blood.
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