K-number	K182781
Device name	PTS Professional Chemistry Kit
Applicant	Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
Product code	CGA
Device class	Class II
Decision date	Dec 21, 2018
Decision	Unknown
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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PTS Professional Chemistry Kit

Everything you need for a 510(k) submission. Nothing you don't.