Cleared Traditional

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

K163570 · Carolina Liquid Chemistries Corporation · Toxicology

Aug 2017

Decision

239d

Days

Class 2

Risk

About This 510(k) Submission

K163570 is an FDA 510(k) clearance for the Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM), a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Carolina Liquid Chemistries Corporation (Winston-Salem, US). The FDA issued a Cleared decision on August 15, 2017, 239 days after receiving the submission on December 19, 2016. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number	K163570 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2016
Decision Date	August 15, 2017
Days to Decision	239 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF