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FDA 510(k)

BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K000318 · 2000-02-28

ApplicantBionostics, Inc.
Decision Date2000-02-28
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 2000-02-28 under 510(k) number K000318. 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 BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM?

BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2000-02-28. The listed applicant is Bionostics, Inc.. The 510(k) number is K000318.

When did BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2000-02-28, under 510(k) number K000318.

Who is the listed applicant for BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM?

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 BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM 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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