Cleared Special

RAPIDTOX

K053359 · American Bio Medica Corp. · Toxicology
May 2006
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K053359 is an FDA 510(k) clearance for the RAPIDTOX, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by American Bio Medica Corp. (Beverly, US). The FDA issued a Cleared decision on May 25, 2006, 174 days after receiving the submission on December 2, 2005. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K053359 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2005
Decision Date May 25, 2006
Days to Decision 174 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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