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FDA 510(k)

ROMA (HE4 EIA + ARCHITECT CA 125 II)

K-Number: K103358 · 2011-09-01

ApplicantFujirebio Diagnostics,Inc.
Decision Date2011-09-01
Product CodeONX
Advisory CommitteeOB
DecisionUnknown

Device Summary

ROMA (HE4 EIA + ARCHITECT CA 125 II) 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 2011-09-01 under 510(k) number K103358. The device is classified under product code ONX. It was reviewed by the OB advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ROMA (HE4 EIA + ARCHITECT CA 125 II)?

ROMA (HE4 EIA + ARCHITECT CA 125 II) is a medical device that received FDA 510(k) clearance on 2011-09-01. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K103358.

When did ROMA (HE4 EIA + ARCHITECT CA 125 II) receive FDA 510(k) clearance?

ROMA (HE4 EIA + ARCHITECT CA 125 II) received FDA 510(k) clearance on 2011-09-01, under 510(k) number K103358.

Who is the listed applicant for ROMA (HE4 EIA + ARCHITECT CA 125 II)?

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 ROMA (HE4 EIA + ARCHITECT CA 125 II)?

The FDA product code for ROMA (HE4 EIA + ARCHITECT CA 125 II) 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.

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