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510(k) Data Aggregation
K Number
K221383Device Name
MedtFine Blood Lancet
Manufacturer
Shanghai Carelife International Trading Co. Ltd.
Date Cleared
2022-09-21
(131 days)
Product Code
QRK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Carelife International Trading Co. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MedtFine Blood Lancet is intended for use together with a lancing device of skin to obtain a drop of capillary blood from fingertip or from alternative sites.
Device Description
MedtFine Blood Lancet is a small medical device used for capillary blood sampling. It is similar to a small scalpel with a double-edged needle used to make punctures, such as a fingerstick, to obtain small blood specimens. The device consists of a needle sheath, a hub, and a needle and provided sterility that is sterilized by gamma radiation. The device has three types listed in table 1 with recognized color. The device is an over-the-counter instrument equipped with a lancing device that patients mostly use during blood monitoring. However, in this case, it doesn't contain a lancing device, only the lancet. The proposed device is a universal device that can be fitted with most common marked lancing devices.
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