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FDA 510(k)

GLUCOSE METER-CHECK SOLUTION FOR BAYER

K-Number: K123966 · 2013-01-25

ApplicantBionostics, Inc.
Decision Date2013-01-25
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE METER-CHECK SOLUTION FOR BAYER is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 2013-01-25 under 510(k) number K123966. 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 GLUCOSE METER-CHECK SOLUTION FOR BAYER?

GLUCOSE METER-CHECK SOLUTION FOR BAYER is a medical device that received FDA 510(k) clearance on 2013-01-25. The listed applicant is Bionostics, Inc.. The 510(k) number is K123966.

When did GLUCOSE METER-CHECK SOLUTION FOR BAYER receive FDA 510(k) clearance?

GLUCOSE METER-CHECK SOLUTION FOR BAYER received FDA 510(k) clearance on 2013-01-25, under 510(k) number K123966.

Who is the listed applicant for GLUCOSE METER-CHECK SOLUTION FOR BAYER?

The FDA 510(k) record lists Bionostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOSE METER-CHECK SOLUTION FOR BAYER?

The FDA product code for GLUCOSE METER-CHECK SOLUTION FOR BAYER 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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