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FDA 510(k)

FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL

K-Number: K110641 · 2011-05-27

ApplicantFujirebio Diagnostics,Inc.
Decision Date2011-05-27
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FUJIREBIO DIAGNOSTICS VITAMIN D 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 2011-05-27 under 510(k) number K110641. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL?

FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL is a medical device that received FDA 510(k) clearance on 2011-05-27. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K110641.

When did FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL receive FDA 510(k) clearance?

FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL received FDA 510(k) clearance on 2011-05-27, under 510(k) number K110641.

Who is the listed applicant for FUJIREBIO DIAGNOSTICS VITAMIN D 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 VITAMIN D CONTROL?

The FDA product code for FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL is JJX.

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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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