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510(k) Data Aggregation
K Number
K223201Device Name
TAP Lancet
Manufacturer
YourBio Health, Inc.
Date Cleared
2023-04-19
(187 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
YourBio Health, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TAP Lancet is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
Device Description
The TAP Lancet is a single-use blood lancing device with an integral sharps injury prevention feature intended for producing microliter capillary whole blood samples. The TAP Lancet comprises a lancing module and a vacuum creation module which operate in an entirely mechanical fashion. The device uses a lancet and vacuum to initiate blood flow from the capillary bed in the upper arm. To use the device, the user removes that TAP Lancet from a sterile barrier package. Next, the user removes a protective liner from the bottom of the device to expose a layer of medical adhesive and places the device onto the
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