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

FDA 510(k) K181915 · Ixensor Co, Ltd.

Substantially Equivalent

510(k) numberK181915

Submission

Device name
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
Applicant
Ixensor Co, Ltd.
Taipei City, TW
Received
July 17, 2018
Decision date
April 12, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LCP – Assay, Glycosylated Hemoglobin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7470
Specialty
Hematology

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More from Abbott Rapid Diagnostics

510(k)DeviceDecision
K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitLCP · Traditional 10/29/2019SE
K163087PixoTest Blood Glucose Monitoring SystemNBW · Traditional 11/02/2017SE

Questions and answers

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

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit (K181915) received a 510(k) decision of Substantially Equivalent on April 12, 2019, 269 days after the submission was received.

What is the product code of K181915?

The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.