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FDA 510(k)

Elecsys BRAHMS PCT

K-Number: K173927 · 2018-07-06

ApplicantRoche Diagnostics
Decision Date2018-07-06
Product CodePRI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Elecsys BRAHMS PCT is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2018-07-06 under approval number K173927. 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 Elecsys BRAHMS PCT?

Elecsys BRAHMS PCT is a medical device that received FDA 510(k) clearance on 2018-07-06. It is manufactured by Roche Diagnostics. The 510(k) number is K173927.

When was Elecsys BRAHMS PCT approved by the FDA?

Elecsys BRAHMS PCT received FDA 510(k) clearance on 2018-07-06, under approval number K173927.

What company makes Elecsys BRAHMS PCT?

Elecsys BRAHMS PCT is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys BRAHMS PCT?

The FDA product code for Elecsys BRAHMS PCT is PRI.

Other Devices by Roche Diagnostics

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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 K162827VIDAS B.R.A.H.M.S. PCT (PCT)bioMerieux, Inc. 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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