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FDA 510(k)

XSTAT 30 Pouch

K-Number: K210676 · 2021-08-27

ApplicantRevmedx, Inc.
Decision Date2021-08-27
Product CodePGZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XSTAT 30 Pouch is a medical device manufactured by Revmedx, Inc.. It received FDA 510(k) clearance on 2021-08-27 under approval number K210676. 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 30 Pouch?

XSTAT 30 Pouch is a medical device that received FDA 510(k) clearance on 2021-08-27. It is manufactured by Revmedx, Inc.. The 510(k) number is K210676.

When was XSTAT 30 Pouch approved by the FDA?

XSTAT 30 Pouch received FDA 510(k) clearance on 2021-08-27, under approval number K210676.

What company makes XSTAT 30 Pouch?

XSTAT 30 Pouch is manufactured by Revmedx, Inc..

What is the FDA product code for XSTAT 30 Pouch?

The FDA product code for XSTAT 30 Pouch 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 K253290XSTAT P15

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. K253290XSTAT P15Revmedx, 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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