Name: Predicase
Price: 199 USD

K-number	K222084
Device name	OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie
Applicant	Asahi Polyslider Co., Ltd.
Product code	FMK
Device class	Class II
Decision date	Nov 2, 2022
Decision	Substantially Equivalent
Regulation	878.4850

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Source

View the full FDA submission: accessdata.fda.gov

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OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie

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