Cleared Traditional

RAPIDONE-BUPRENORPHINE TEST

K060760 · American Bio Medica Corp. · Toxicology
Aug 2006
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K060760 is an FDA 510(k) clearance for the RAPIDONE-BUPRENORPHINE TEST, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by American Bio Medica Corp. (Columbia, US). The FDA issued a Cleared decision on August 7, 2006, 139 days after receiving the submission on March 21, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K060760 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2006
Decision Date August 07, 2006
Days to Decision 139 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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