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FDA 510(k)

FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20

K-Number: K101809 · 2010-10-05

ApplicantFujirebio Diagnostics,Inc.
Decision Date2010-10-05
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 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 2010-10-05 under 510(k) number K101809. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20?

FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 is a medical device that received FDA 510(k) clearance on 2010-10-05. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K101809.

When did FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 receive FDA 510(k) clearance?

FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 received FDA 510(k) clearance on 2010-10-05, under 510(k) number K101809.

Who is the listed applicant for FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20?

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 MODEL 108-20?

The FDA product code for FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 is JJY.

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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.

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