Name: Predicase
Price: 199 USD

K-number	K182931
Device name	VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag
Applicant	Steris Corporations
Product code	FRC
Device class	Class II
Decision date	Nov 20, 2018
Decision	Substantially Equivalent
Regulation	880.2800

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag

Everything you need for a 510(k) submission. Nothing you don't.