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FDA 510(k)

GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT

K-Number: K112352 · 2011-12-23

ApplicantBionostics, Inc.
Decision Date2011-12-23
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 2011-12-23 under 510(k) number K112352. 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 CONTROL FOR NIPRO TRUERESULT?

GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT is a medical device that received FDA 510(k) clearance on 2011-12-23. The listed applicant is Bionostics, Inc.. The 510(k) number is K112352.

When did GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT receive FDA 510(k) clearance?

GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT received FDA 510(k) clearance on 2011-12-23, under 510(k) number K112352.

Who is the listed applicant for GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT?

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 CONTROL FOR NIPRO TRUERESULT?

The FDA product code for GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT 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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