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510(k) K193406

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2022
Date Received
December 9, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

  • K182781 — PTS Professional Chemistry Kit (December 21, 2018)
  • K162282 — CardioChek Plus Test System, CardioChek Home Test System (December 22, 2016)

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