Cleared Traditional

VERDICT-II PROPOXYPHENE

K020787 · Medtox Diagnostics, Inc. · Toxicology
May 2002
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K020787 is an FDA 510(k) clearance for the VERDICT-II PROPOXYPHENE, a Enzyme Immunoassay, Propoxyphene (Class II — Special Controls, product code JXN), submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on May 2, 2002, 52 days after receiving the submission on March 11, 2002. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3700.

Submission Details

510(k) Number K020787 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2002
Decision Date May 02, 2002
Days to Decision 52 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

Similar Devices — JXN Enzyme Immunoassay, Propoxyphene

All 21
Wondfo Propoxyphene Urine Test
K152495 · Guangzhou Wondfo Biotech Co., Ltd. · Nov 2015
FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD
K122752 · Branan Medical Corp. · Jan 2013
PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL
K111363 · Medica Corp. · Dec 2011
ONLINE DAT PROPOXYPHENE PLUS
K043303 · Roche Diagnostics Corp. · Mar 2005
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE
K040445 · ACON Laboratories, Inc. · May 2004
'RAPID ONE' - PROPOXYPHENE TEST
K030835 · American Bio Medica Corp. · May 2003