PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit— 510(k) K181915

Name: FDA 510(k) clearance K181915
Creator: U.S. Food and Drug Administration
Published: 2019-04-12

Substantially Equivalent

Ixensor Co, Ltd.

FDA 510(k) clearance K181915 for PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit, Substantially Equivalent on 2019-04-12. Applicant: Ixensor Co, Ltd.. Device class: 2.

Clearance details

Applicant: Ixensor Co, Ltd.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2018-07-17
Decision date: 2019-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

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