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510(k) K182781

PTS Professional Chemistry Kit by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics — Product Code CGA

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 21, 2018
Date Received
October 1, 2018
Clearance Type
Traditional
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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