Cleared Traditional

RAPIDONE-COCAINE-150 TEST

K053422 · American Bio Medica Corp. · Toxicology
Jun 2006
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K053422 is an FDA 510(k) clearance for the RAPIDONE-COCAINE-150 TEST, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by American Bio Medica Corp. (Columbia, US). The FDA issued a Cleared decision on June 15, 2006, 189 days after receiving the submission on December 8, 2005. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K053422 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2005
Decision Date June 15, 2006
Days to Decision 189 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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