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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 the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2018-07-06 under 510(k) 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. The listed applicant is Roche Diagnostics. The 510(k) number is K173927.

When did Elecsys BRAHMS PCT receive FDA 510(k) clearance?

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

Who is the listed applicant for Elecsys BRAHMS PCT?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elecsys BRAHMS PCT?

The FDA product code for Elecsys BRAHMS PCT is PRI.

Other records listing Roche Diagnostics as applicant

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Related Devices (Code: PRI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220262Dimension EXL LOCI BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc.K192815Elecsys BRAHMS PCTRoche DiagnosticsK173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN VerifiersDiaSorin, Inc.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 DiagnosticsK171338B R A H M S PCT sensitive KRYPTORBrahms GmbH

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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