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FDA 510(k)

FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL

K-Number: K103676 · 2011-07-19

ApplicantFujirebio Diagnostics,Inc.
Decision Date2011-07-19
Product CodeOIU
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL 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 2011-07-19 under 510(k) number K103676. 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 FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL?

FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL is a medical device that received FDA 510(k) clearance on 2011-07-19. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K103676.

When did FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL receive FDA 510(k) clearance?

FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL received FDA 510(k) clearance on 2011-07-19, under 510(k) number K103676.

Who is the listed applicant for FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL?

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 FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL?

The FDA product code for FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL 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.

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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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