K-number	K253290
Device name	XSTAT P15
Applicant	Revmedx, Inc.
Product code	PGZ
Device class	Class II
Decision date	Nov 12, 2025
Decision	Substantially Equivalent
Regulation	878.4452

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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XSTAT P15

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