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FDA 510(k)

GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE

K-Number: K013147 · 2001-10-24

ApplicantBionostics, Inc.
Decision Date2001-10-24
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 2001-10-24 under 510(k) number K013147. 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 CONTROL SOLUTION FOR THERASENSE FREESTYLE?

GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE is a medical device that received FDA 510(k) clearance on 2001-10-24. The listed applicant is Bionostics, Inc.. The 510(k) number is K013147.

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

GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE received FDA 510(k) clearance on 2001-10-24, under 510(k) number K013147.

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

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 CONTROL SOLUTION FOR THERASENSE FREESTYLE?

The FDA product code for GLUCOSE CONTROL SOLUTION FOR THERASENSE 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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