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FDA 510(k)

HE4 EIA, MODEL: 404-10 US

K-Number: K072939 · 2008-06-09

ApplicantFujirebio Diagnostics,Inc.
Decision Date2008-06-09
Product CodeOIU
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HE4 EIA, MODEL: 404-10 US 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 2008-06-09 under 510(k) number K072939. The device is classified under product code OIU. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HE4 EIA, MODEL: 404-10 US?

HE4 EIA, MODEL: 404-10 US is a medical device that received FDA 510(k) clearance on 2008-06-09. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K072939.

When did HE4 EIA, MODEL: 404-10 US receive FDA 510(k) clearance?

HE4 EIA, MODEL: 404-10 US received FDA 510(k) clearance on 2008-06-09, under 510(k) number K072939.

Who is the listed applicant for HE4 EIA, MODEL: 404-10 US?

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 HE4 EIA, MODEL: 404-10 US?

The FDA product code for HE4 EIA, MODEL: 404-10 US is OIU.

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Related Devices (Code: OIU)

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.

K112624ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5Roche DiagnosticsK103676FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROLFujirebio Diagnostics,Inc.K093957ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,Fujirebio Diagnostics,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.

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