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FDA 510(k)

MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3

K-Number: K012430 · 2001-08-27

ApplicantBionostics, Inc.
Decision Date2001-08-27
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 2001-08-27 under 510(k) number K012430. 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 MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3?

MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 is a medical device that received FDA 510(k) clearance on 2001-08-27. The listed applicant is Bionostics, Inc.. The 510(k) number is K012430.

When did MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 receive FDA 510(k) clearance?

MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 received FDA 510(k) clearance on 2001-08-27, under 510(k) number K012430.

Who is the listed applicant for MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3?

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 MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3?

The FDA product code for MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 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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