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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 the device name listed in this FDA 510(k) record. The listed applicant is Revmedx, Inc.. It received FDA 510(k) clearance on 2016-07-28 under 510(k) 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. The listed applicant is Revmedx, Inc.. The 510(k) number is K161020.

When did XSTAT-12, 3-Pack, XSTAT-12, 1-Pack receive FDA 510(k) clearance?

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

Who is the listed applicant for XSTAT-12, 3-Pack, XSTAT-12, 1-Pack?

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

The FDA product code for XSTAT-12, 3-Pack, XSTAT-12, 1-Pack 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 P15K210676XSTAT 30 PouchK180051XSTAT 30, 1-PackK170334XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack

Related Devices (Code: PGZ)

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 P15Revmedx, Inc.K210676XSTAT 30 PouchRevmedx, Inc.K180051XSTAT 30, 1-PackRevmedx, Inc.K170334XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackRevmedx, 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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