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FDA 510(k)

GLUCOSE CONTROL SOLUTION FOR BD LATITUDE

K-Number: K021697 · 2002-07-12

ApplicantBionostics, Inc.
Decision Date2002-07-12
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE CONTROL SOLUTION FOR BD LATITUDE is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 2002-07-12 under 510(k) number K021697. 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 BD LATITUDE?

GLUCOSE CONTROL SOLUTION FOR BD LATITUDE is a medical device that received FDA 510(k) clearance on 2002-07-12. The listed applicant is Bionostics, Inc.. The 510(k) number is K021697.

When did GLUCOSE CONTROL SOLUTION FOR BD LATITUDE receive FDA 510(k) clearance?

GLUCOSE CONTROL SOLUTION FOR BD LATITUDE received FDA 510(k) clearance on 2002-07-12, under 510(k) number K021697.

Who is the listed applicant for GLUCOSE CONTROL SOLUTION FOR BD LATITUDE?

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 BD LATITUDE?

The FDA product code for GLUCOSE CONTROL SOLUTION FOR BD LATITUDE 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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