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FDA 510(k)

FDI GLUCOSE CONTROL SOLUTIONS

K-Number: K102260 · 2010-09-24

ApplicantFujirebio Diagnostics,Inc.
Decision Date2010-09-24
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FDI GLUCOSE CONTROL SOLUTIONS 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 2010-09-24 under 510(k) number K102260. 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 FDI GLUCOSE CONTROL SOLUTIONS?

FDI GLUCOSE CONTROL SOLUTIONS is a medical device that received FDA 510(k) clearance on 2010-09-24. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K102260.

When did FDI GLUCOSE CONTROL SOLUTIONS receive FDA 510(k) clearance?

FDI GLUCOSE CONTROL SOLUTIONS received FDA 510(k) clearance on 2010-09-24, under 510(k) number K102260.

Who is the listed applicant for FDI GLUCOSE CONTROL SOLUTIONS?

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 FDI GLUCOSE CONTROL SOLUTIONS?

The FDA product code for FDI GLUCOSE CONTROL SOLUTIONS 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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