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510(k) K192369

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit by Ixensor Co, Ltd. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2019
Date Received
August 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

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