Cleared Traditional

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

K181915 · Ixensor Co, Ltd. · Chemistry

Apr 2019

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K181915 is an FDA 510(k) clearance for the PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Ixensor Co, Ltd. (Taipei City, TW). The FDA issued a Cleared decision on April 12, 2019, 269 days after receiving the submission on July 17, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number	K181915 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 17, 2018
Decision Date	April 12, 2019
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF