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510(k) K162282

CardioChek Plus Test System, CardioChek Home Test System by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2016
Date Received
August 15, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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