Cleared Traditional

'RAPID ONE' - PROPOXYPHENE TEST

K030835 · American Bio Medica Corp. · Toxicology
May 2003
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K030835 is an FDA 510(k) clearance for the 'RAPID ONE' - PROPOXYPHENE TEST, a Enzyme Immunoassay, Propoxyphene (Class II — Special Controls, product code JXN), submitted by American Bio Medica Corp. (Columbia, US). The FDA issued a Cleared decision on May 22, 2003, 66 days after receiving the submission on March 17, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3700.

Submission Details

510(k) Number K030835 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2003
Decision Date May 22, 2003
Days to Decision 66 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code JXN — Enzyme Immunoassay, Propoxyphene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3700

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