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FDA 510(k)

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack

K-Number: K161020 · 2016-07-28

ApplicantRevmedx, Inc.
Decision Date2016-07-28
Product CodePGZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack is a medical device manufactured by Revmedx, Inc.. It received FDA 510(k) clearance on 2016-07-28 under approval number K161020. 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-12, 3-Pack, XSTAT-12, 1-Pack?

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack is a medical device that received FDA 510(k) clearance on 2016-07-28. It is manufactured by Revmedx, Inc.. The 510(k) number is K161020.

When was XSTAT-12, 3-Pack, XSTAT-12, 1-Pack approved by the FDA?

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack received FDA 510(k) clearance on 2016-07-28, under approval number K161020.

What company makes XSTAT-12, 3-Pack, XSTAT-12, 1-Pack?

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack is manufactured by Revmedx, Inc..

What is the FDA product code for XSTAT-12, 3-Pack, XSTAT-12, 1-Pack?

The FDA product code for XSTAT-12, 3-Pack, XSTAT-12, 1-Pack is PGZ.

Other Devices by Revmedx, Inc.

K170334XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack K180051XSTAT 30, 1-Pack K210676XSTAT 30 Pouch K253290XSTAT P15

Related Devices (Code: PGZ)

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. 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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