Cleared Traditional

Rapid Tox Cup II

K170222 · American Bio Medica Corp. · Toxicology
Aug 2017
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K170222 is an FDA 510(k) clearance for the Rapid Tox Cup II, a Gas Chromatography, Methamphetamine (Class II — Special Controls, product code LAF), submitted by American Bio Medica Corp. (Kinderhook, US). The FDA issued a Cleared decision on August 15, 2017, 202 days after receiving the submission on January 25, 2017. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K170222 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2017
Decision Date August 15, 2017
Days to Decision 202 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LAF — Gas Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

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