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FDA 510(k)

Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set

K-Number: K172713 · 2017-12-10

ApplicantFujirebio Diagnostics,Inc.
Decision Date2017-12-10
Product CodePRI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set is a medical device manufactured by Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2017-12-10 under approval number K172713. 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 Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set?

Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set is a medical device that received FDA 510(k) clearance on 2017-12-10. It is manufactured by Fujirebio Diagnostics,Inc.. The 510(k) number is K172713.

When was Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set approved by the FDA?

Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set received FDA 510(k) clearance on 2017-12-10, under approval number K172713.

What company makes Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set?

Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set is manufactured by Fujirebio Diagnostics,Inc..

What is the FDA product code for Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set?

The FDA product code for Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set is PRI.

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Related Devices (Code: PRI)

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. 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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