Cleared Traditional

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

K192369 · Ixensor Co, Ltd. · Chemistry

Oct 2019

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K192369 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 October 29, 2019, 60 days after receiving the submission on August 30, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number	K192369 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2019
Decision Date	October 29, 2019
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF