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FDA 510(k)

Elecsys BRAHMS PCT

K-Number: K192815 · 2020-03-09

ApplicantRoche Diagnostics
Decision Date2020-03-09
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 2020-03-09 under approval number K192815. 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 2020-03-09. It is manufactured by Roche Diagnostics. The 510(k) number is K192815.

When was Elecsys BRAHMS PCT approved by the FDA?

Elecsys BRAHMS PCT received FDA 510(k) clearance on 2020-03-09, under approval number K192815.

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

DEN150057Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker K160910Elecsys Syphilis K153607ROMA Calculation Tool Using Elecsys Assays K160729Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 K152227Elecsys Cortisol II, Cortisol II CalSet

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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. K173927Elecsys BRAHMS PCTRoche Diagnostics K173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN VerifiersDiaSorin, 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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