K-number	K210676
Device name	XSTAT 30 Pouch
Applicant	Revmedx, Inc.
Product code	PGZ
Device class	Class II
Decision date	Aug 27, 2021
Decision	Substantially Equivalent
Regulation	878.4452

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Source

View the full FDA submission: accessdata.fda.gov

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XSTAT 30 Pouch

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