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FDA 510(k)

XSTAT P15

K-Number: K253290 · 2025-11-12

ApplicantRevmedx, Inc.
Decision Date2025-11-12
Product CodePGZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XSTAT P15 is a medical device manufactured by Revmedx, Inc.. It received FDA 510(k) clearance on 2025-11-12 under approval number K253290. The device is classified under product code PGZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XSTAT P15?

XSTAT P15 is a medical device that received FDA 510(k) clearance on 2025-11-12. It is manufactured by Revmedx, Inc.. The 510(k) number is K253290.

When was XSTAT P15 approved by the FDA?

XSTAT P15 received FDA 510(k) clearance on 2025-11-12, under approval number K253290.

What company makes XSTAT P15?

XSTAT P15 is manufactured by Revmedx, Inc..

What is the FDA product code for XSTAT P15?

The FDA product code for XSTAT P15 is PGZ.

Other Devices by Revmedx, Inc.

K161020XSTAT-12, 3-Pack, XSTAT-12, 1-Pack K170334XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack K180051XSTAT 30, 1-Pack K210676XSTAT 30 Pouch

Related Devices (Code: PGZ)

K161020XSTAT-12, 3-Pack, XSTAT-12, 1-PackRevmedx, Inc. K170334XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackRevmedx, Inc. K180051XSTAT 30, 1-PackRevmedx, Inc. K210676XSTAT 30 PouchRevmedx, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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