Cleared Traditional

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

K213211 · Carolina Liquid Chemistries Corp. · Toxicology
Jan 2022
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K213211 is an FDA 510(k) clearance for the Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Carolina Liquid Chemistries Corp. (Greensboro, US). The FDA issued a Cleared decision on January 27, 2022, 120 days after receiving the submission on September 29, 2021. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K213211 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2021
Decision Date January 27, 2022
Days to Decision 120 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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