Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2017-12-10 under 510(k) 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. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K172713.

When did Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set receive FDA 510(k) clearance?

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 510(k) number K172713.

Who is the listed applicant 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 510(k) record lists Fujirebio Diagnostics,Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Fujirebio Diagnostics,Inc. as applicant

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.

K250925ADVIA Centaur Cytokeratin Fragment 21-1K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioK192524Lumipulse G CA15-3K192380ST AIA-PACK BNPK200997Lumipulse G CA19-9-NK190702Lumipulse G whole PTH

View all 17 devices →

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 DiagnosticsK173927Elecsys BRAHMS PCTRoche DiagnosticsK173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN VerifiersDiaSorin, 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.

↑