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FDA 510(k)

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

K-Number: K192369 · 2019-10-29

ApplicantIxensor Co, Ltd.
Decision Date2019-10-29
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit is the device name listed in this FDA 510(k) record. The listed applicant is Ixensor Co, Ltd.. It received FDA 510(k) clearance on 2019-10-29 under 510(k) number K192369. 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 2019-10-29. The listed applicant is Ixensor Co, Ltd.. The 510(k) number is K192369.

When did PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit receive FDA 510(k) clearance?

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit received FDA 510(k) clearance on 2019-10-29, under 510(k) number K192369.

Who is the listed applicant for PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit?

The FDA 510(k) record lists Ixensor Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Ixensor Co, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181915PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitK163087PixoTest Blood Glucose Monitoring System

Related Devices (Code: LCP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies ASK192987Aina HbA1c Monitoring System 2Jana Care, Inc.K183230OneDraw A1C Test SystemDrawbridge Health, Inc.K181915PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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