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-Nummer: K172713 · 2017-12-10

Entscheidungsdatum2017-12-10

ProduktcodePRI

BeratungsausschussMI

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Weitere Einträge mit Fujirebio Diagnostics,Inc. als Antragsteller

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Verwandte Geräte (Code: PRI)

K220262Dimension EXL LOCI BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc.K192815Elecsys BRAHMS PCTRoche Diagnostics K173927Elecsys BRAHMS PCTRoche Diagnostics K173683LIAISON 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 Kalibratoren, ARCHITECT B.R.A.H.M.S PCT KontrollenFisher Diagnostics K171338B R A H M S PCT sensitive KRYPTORBrahms GmbH

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