Lumipulse G ROMA
K-Number: K160090 · 2016-05-16
ApplicantFujirebio Diagnostics,Inc.
Decision Date2016-05-16
Product CodeONX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Lumipulse G ROMA is a medical device manufactured by Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2016-05-16 under approval 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. It is manufactured by Fujirebio Diagnostics,Inc.. The 510(k) number is K160090.
When was Lumipulse G ROMA approved by the FDA?
Lumipulse G ROMA received FDA 510(k) clearance on 2016-05-16, under approval number K160090.
What company makes Lumipulse G ROMA?
Lumipulse G ROMA is manufactured by Fujirebio Diagnostics,Inc..
What is the FDA product code for Lumipulse G ROMA?
The FDA product code for Lumipulse G ROMA is ONX.
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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.