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FDA 510(k)

XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack

K-Number: K170334 · 2017-05-01

ApplicantRevmedx, Inc.
Decision Date2017-05-01
Product CodePGZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; 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 2017-05-01 under 510(k) number K170334. 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, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack?

XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack is a medical device that received FDA 510(k) clearance on 2017-05-01. The listed applicant is Revmedx, Inc.. The 510(k) number is K170334.

When did XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack receive FDA 510(k) clearance?

XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack received FDA 510(k) clearance on 2017-05-01, under 510(k) number K170334.

Who is the listed applicant for XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; 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 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack?

The FDA product code for XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; 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-PackK161020XSTAT-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.K161020XSTAT-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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