Cleared Traditional

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay

K191638 · Medtest DX · Toxicology

Mar 2020

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K191638 is an FDA 510(k) clearance for the Pointe Scientific Cocaine Metabolite Enzyme Immunoassay, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Medtest DX (Lincoln Park, US). The FDA issued a Cleared decision on March 12, 2020, 267 days after receiving the submission on June 19, 2019. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number	K191638 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 2019
Decision Date	March 12, 2020
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF