FDA 510(k)

Lumipulse G ROMA

K-Number: K160090 · 2016-05-16

Decision Date2016-05-16

Product CodeONX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Lumipulse G ROMA 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 2016-05-16 under 510(k) number K160090. The device is classified under product code ONX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lumipulse G ROMA?

Lumipulse G ROMA is a medical device that received FDA 510(k) clearance on 2016-05-16. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K160090.

When did Lumipulse G ROMA receive FDA 510(k) clearance?

Lumipulse G ROMA received FDA 510(k) clearance on 2016-05-16, under 510(k) number K160090.

Who is the listed applicant for Lumipulse G ROMA?

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 ROMA?

The FDA product code for Lumipulse G ROMA is ONX.

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 21-1 K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio K192524Lumipulse G CA15-3 K192380ST AIA-PACK BNP K200997Lumipulse G CA19-9-N K190702Lumipulse G whole PTH

View all 17 devices →

Related Devices (Code: ONX)

K153607ROMA Calculation Tool Using Elecsys AssaysRoche Diagnostics K151502ARCHITECT ROMAFujirebio Diagnostics,Inc.K150588OVA1 Next GenerationVermillion, 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.