Name: Predicase
Price: 199 USD

K-number	K213211
Device name	Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
Applicant	Carolina Liquid Chemistries Corp.
Product code	DIO
Device class	Class II
Decision date	Jan 27, 2022
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 Enzyme Immunoassay (COCM) Test System

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