Cleared Traditional

FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

K142408 · Polymed Therapeutics, Inc. · Toxicology
Sep 2014
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K142408 is an FDA 510(k) clearance for the FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Polymed Therapeutics, Inc. (Houston, US). The FDA issued a Cleared decision on September 25, 2014, 28 days after receiving the submission on August 28, 2014. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K142408 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2014
Decision Date September 25, 2014
Days to Decision 28 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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