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FDA 510(k)

Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

K-Number: K220262 · 2022-08-26

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2022-08-26
Product CodePRI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Dimension EXL LOCI BRAHMS Procalcitonin (PCT) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2022-08-26 under approval number K220262. 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 Dimension EXL LOCI BRAHMS Procalcitonin (PCT)?

Dimension EXL LOCI BRAHMS Procalcitonin (PCT) is a medical device that received FDA 510(k) clearance on 2022-08-26. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K220262.

When was Dimension EXL LOCI BRAHMS Procalcitonin (PCT) approved by the FDA?

Dimension EXL LOCI BRAHMS Procalcitonin (PCT) received FDA 510(k) clearance on 2022-08-26, under approval number K220262.

What company makes Dimension EXL LOCI BRAHMS Procalcitonin (PCT)?

Dimension EXL LOCI BRAHMS Procalcitonin (PCT) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for Dimension EXL LOCI BRAHMS Procalcitonin (PCT)?

The FDA product code for Dimension EXL LOCI BRAHMS Procalcitonin (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 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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