Name: Predicase
Price: 199 USD

K-number	K163570
Device name	Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
Applicant	Carolina Liquid Chemistries Corporation
Product code	DIO
Device class	Class II
Decision date	Aug 15, 2017
Decision	Substantially Equivalent
Regulation	862.3250

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Source

View the full FDA submission: accessdata.fda.gov

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Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)

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