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FDA 510(k)

RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS

K-Number: K081478 · 2008-10-06

ApplicantBionostics, Inc.
Decision Date2008-10-06
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 2008-10-06 under 510(k) number K081478. 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 RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS?

RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS is a medical device that received FDA 510(k) clearance on 2008-10-06. The listed applicant is Bionostics, Inc.. The 510(k) number is K081478.

When did RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS receive FDA 510(k) clearance?

RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS received FDA 510(k) clearance on 2008-10-06, under 510(k) number K081478.

Who is the listed applicant for RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS?

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 RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS?

The FDA product code for RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS 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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