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FDA 510(k)

FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA

K-Number: K123612 · 2013-01-17

ApplicantFujirebio Diagnostics,Inc.
Decision Date2013-01-17
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA 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 2013-01-17 under 510(k) number K123612. 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 USE WITH ACCU-CHEK AVIVA?

FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA is a medical device that received FDA 510(k) clearance on 2013-01-17. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K123612.

When did FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA receive FDA 510(k) clearance?

FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA received FDA 510(k) clearance on 2013-01-17, under 510(k) number K123612.

Who is the listed applicant for FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA?

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 USE WITH ACCU-CHEK AVIVA?

The FDA product code for FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA 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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