FDA 510(k)

ARCHITECT ROMA

K-Number: K151502 · 2016-04-28

Decision Date2016-04-28

Product CodeONX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

ARCHITECT 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 2016-04-28 under 510(k) 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. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K151502.

When did ARCHITECT ROMA receive FDA 510(k) clearance?

ARCHITECT ROMA received FDA 510(k) clearance on 2016-04-28, under 510(k) number K151502.

Who is the listed applicant for ARCHITECT 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 ARCHITECT ROMA?

The FDA product code for ARCHITECT 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.

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Related Devices (Code: ONX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.