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FDA 510(k)

FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE

K-Number: K103450 · 2011-01-25

ApplicantFujirebio Diagnostics,Inc.
Decision Date2011-01-25
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE 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 2011-01-25 under 510(k) number K103450. 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 SOLUTION FOR FREESTYLE?

FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE is a medical device that received FDA 510(k) clearance on 2011-01-25. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K103450.

When did FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE receive FDA 510(k) clearance?

FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE received FDA 510(k) clearance on 2011-01-25, under 510(k) number K103450.

Who is the listed applicant for FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE?

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 SOLUTION FOR FREESTYLE?

The FDA product code for FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE 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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