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510(k) K221546

OneTouch Delica Plus Lancing System by Asahi Polyslider Co., Ltd. — Product Code QRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2022
Date Received
May 27, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multiple Use Blood Lancet For Single Patient Use Only
Device Class
Class II
Regulation Number
878.4850
Review Panel
SU
Submission Type

A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Other clearances by Asahi Polyslider Co., Ltd.

  • K222084 — OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plu (November 2, 2022)

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