Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)— 510(k) K163570

Name: FDA 510(k) clearance K163570
Creator: U.S. Food and Drug Administration
Published: 2017-08-15

Substantially Equivalent

Carolina Liquid Chemistries Corporation

FDA 510(k) clearance K163570 for Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM), Substantially Equivalent on 2017-08-15. Applicant: Carolina Liquid Chemistries Corporation. Device class: 2.

Clearance details

Applicant: Carolina Liquid Chemistries Corporation
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2016-12-19
Decision date: 2017-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

Download summary PDF View on FDA.gov ↗

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