510(k) K122752

Device: FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD
Applicant: BRANAN MEDICAL CORP.
510(k) number: K122752
Product code: JXN
Decision: Substantially Equivalent (SESE)
Decision date: 2013-01-30
Date received: 2012-09-07
Regulation: 862.3700
Classification name: Enzyme Immunoassay, Propoxyphene
Medical specialty: Toxicology
Review panel: Toxicology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K152495	Wondfo Propoxyphene Urine Test	Guangzhou Wondfo Biotech Co., Ltd.	2015-11-23
K111363	PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL	Medica Corp.	2011-12-06
K043303	ONLINE DAT PROPOXYPHENE PLUS	Roche Diagnostics Corp.	2005-03-11
K040445	ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE	ACON Laboratories, Inc.	2004-05-19
K030835	'RAPID ONE' - PROPOXYPHENE TEST	American Bio Medica Corp.	2003-05-22
K023795	PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)	Lin-Zhi International, Inc.	2003-01-21
K022915	INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST	Alfa Scientific Designs, Inc.	2002-11-29
K020787	VERDICT-II PROPOXYPHENE	Medtox Diagnostics, Inc.	2002-05-02
K013100	PROPOXYPHENE	Abbott Laboratories	2002-03-20
K011163	MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229	Syva Co., Dade Behring, Inc.	2001-05-10
K993981	SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL	Syva Co.	2000-02-01
K983700	MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE	Roche Diagnostic Systems, Inc.	1998-12-11
K955675	SYNCHRON SYSTEMS PROPOXYPHENE REAGENT	Beckman Instruments, Inc.	1996-02-09
K951133	CEDIA DAU PROPOXYPHENE ASSAY	Microgenics Corp.	1995-05-02
K944372	STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA	Solarcare, Inc.	1995-02-08

summary

Decision Summary