ARCHITECT ROMA
K-Number: K151502 · 2016-04-28
ApplicantFujirebio Diagnostics,Inc.
Decision Date2016-04-28
Product CodeONX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
ARCHITECT ROMA is a medical device manufactured by Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2016-04-28 under approval number K151502. 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 ARCHITECT ROMA?
ARCHITECT ROMA is a medical device that received FDA 510(k) clearance on 2016-04-28. It is manufactured by Fujirebio Diagnostics,Inc.. The 510(k) number is K151502.
When was ARCHITECT ROMA approved by the FDA?
ARCHITECT ROMA received FDA 510(k) clearance on 2016-04-28, under approval number K151502.
What company makes ARCHITECT ROMA?
ARCHITECT ROMA is manufactured by Fujirebio Diagnostics,Inc..
What is the FDA product code for ARCHITECT ROMA?
The FDA product code for ARCHITECT 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.