PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit— 510(k) K192369

Substantially Equivalent

Ixensor Co, Ltd.

FDA 510(k) clearance K192369 for PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit, Substantially Equivalent on 2019-10-29. Applicant: Ixensor Co, Ltd..

Clearance details

Applicant: Ixensor Co, Ltd.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2019-08-30
Decision date: 2019-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

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