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FDA 510(k)

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

K-Number: K181915 · 2019-04-12

ApplicantIxensor Co, Ltd.
Decision Date2019-04-12
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit is a medical device manufactured by Ixensor Co, Ltd.. It received FDA 510(k) clearance on 2019-04-12 under approval number K181915. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit?

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit is a medical device that received FDA 510(k) clearance on 2019-04-12. It is manufactured by Ixensor Co, Ltd.. The 510(k) number is K181915.

When was PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit approved by the FDA?

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit received FDA 510(k) clearance on 2019-04-12, under approval number K181915.

What company makes PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit?

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit is manufactured by Ixensor Co, Ltd..

What is the FDA product code for PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit?

The FDA product code for PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit is LCP.

Related Clinical Trials

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Other Devices by Ixensor Co, Ltd.

K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

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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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