FDA 510(k)

XSTAT 30 Pouch

K-Number: K210676 · 2021-08-27

Decision Date2021-08-27

Product CodePGZ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

XSTAT 30 Pouch is the device name listed in this FDA 510(k) record. The listed applicant is Revmedx, Inc.. It received FDA 510(k) clearance on 2021-08-27 under 510(k) 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. The listed applicant is Revmedx, Inc.. The 510(k) number is K210676.

When did XSTAT 30 Pouch receive FDA 510(k) clearance?

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

Who is the listed applicant for XSTAT 30 Pouch?

The FDA 510(k) record lists Revmedx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XSTAT 30 Pouch?

The FDA product code for XSTAT 30 Pouch is PGZ.

Other records listing Revmedx, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253290XSTAT P15 K180051XSTAT 30, 1-Pack K170334XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack K161020XSTAT-12, 3-Pack, XSTAT-12, 1-Pack

Related Devices (Code: PGZ)

K253290XSTAT P15Revmedx, Inc.K180051XSTAT 30, 1-PackRevmedx, Inc.K170334XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackRevmedx, Inc.K161020XSTAT-12, 3-Pack, XSTAT-12, 1-PackRevmedx, Inc.

Official Source

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