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 a medical device manufactured by Revmedx, Inc.. It received FDA 510(k) clearance on 2017-05-01 under approval 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. It is manufactured by Revmedx, Inc.. The 510(k) number is K170334.
When was XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack approved by the FDA?
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 approval number K170334.
What company makes 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 manufactured by Revmedx, Inc..
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 Devices by Revmedx, Inc.
Related Devices (Code: PGZ)
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.