Cleared Traditional

RAPID TOX CUP

K073078 · American Bio Medica Corp. · Toxicology
May 2008
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K073078 is an FDA 510(k) clearance for the RAPID TOX CUP, a High Pressure Liquid Chromatography, Methamphetamine (Class II — Special Controls, product code LAG), submitted by American Bio Medica Corp. (Logan Township, US). The FDA issued a Cleared decision on May 30, 2008, 212 days after receiving the submission on October 31, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K073078 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2007
Decision Date May 30, 2008
Days to Decision 212 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LAG — High Pressure Liquid Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

Similar Devices — LAG High Pressure Liquid Chromatography, Methamphetamine

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