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FDA 510(k)

VIDAS B.R.A.H.M.S. PCT (PCT)

K-Number: K162827 · 2017-02-23

ApplicantbioMerieux, Inc.
Decision Date2017-02-23
Product CodePRI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIDAS B.R.A.H.M.S. PCT (PCT) is a medical device manufactured by bioMerieux, Inc.. It received FDA 510(k) clearance on 2017-02-23 under approval number K162827. The device is classified under product code PRI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS B.R.A.H.M.S. PCT (PCT)?

VIDAS B.R.A.H.M.S. PCT (PCT) is a medical device that received FDA 510(k) clearance on 2017-02-23. It is manufactured by bioMerieux, Inc.. The 510(k) number is K162827.

When was VIDAS B.R.A.H.M.S. PCT (PCT) approved by the FDA?

VIDAS B.R.A.H.M.S. PCT (PCT) received FDA 510(k) clearance on 2017-02-23, under approval number K162827.

What company makes VIDAS B.R.A.H.M.S. PCT (PCT)?

VIDAS B.R.A.H.M.S. PCT (PCT) is manufactured by bioMerieux, Inc..

What is the FDA product code for VIDAS B.R.A.H.M.S. PCT (PCT)?

The FDA product code for VIDAS B.R.A.H.M.S. PCT (PCT) is PRI.

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Related Devices (Code: PRI)

K172713Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators setFujirebio Diagnostics,Inc. K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlsFisher Diagnostics K171338B R A H M S PCT sensitive KRYPTORBrahms GmbH K173927Elecsys BRAHMS PCTRoche Diagnostics K173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN VerifiersDiaSorin, Inc. K192815Elecsys BRAHMS PCTRoche Diagnostics

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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