Atlas FDA

JXN

22 FDA 510(k) clearances · Product code

69 daysmedian time to decision
154 days90th percentile
22clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Propoxyphene
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3700
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
Wondfo Propoxyphene Urine Test (K152495)Guangzhou Wondfo Biotech Co., Ltd.2015-11-23
FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD (K122752)Branan Medical Corp.2013-01-30
PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL (K111363)Medica Corp.2011-12-06
ONLINE DAT PROPOXYPHENE PLUS (K043303)Roche Diagnostics Corp.2005-03-11
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE (K040445)ACON Laboratories, Inc.2004-05-19
'RAPID ONE' - PROPOXYPHENE TEST (K030835)American Bio Medica Corp.2003-05-22
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) (K023795)Lin-Zhi International, Inc.2003-01-21
INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST (K022915)Alfa Scientific Designs, Inc.2002-11-29
VERDICT-II PROPOXYPHENE (K020787)Medtox Diagnostics, Inc.2002-05-02
PROPOXYPHENE (K013100)Abbott Laboratories2002-03-20
MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 (K011163)Syva Co., Dade Behring, Inc.2001-05-10
SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (K993981)Syva Co.2000-02-01
MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE (K983700)Roche Diagnostic Systems, Inc.1998-12-11
SYNCHRON SYSTEMS PROPOXYPHENE REAGENT (K955675)Beckman Instruments, Inc.1996-02-09
CEDIA DAU PROPOXYPHENE ASSAY (K951133)Microgenics Corp.1995-05-02
STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA (K944372)Solarcare, Inc.1995-02-08
ABUSCREEN ONLINE PROPOXPHENE (K945195)Roche Diagnostic Systems, Inc.1994-12-09
PROPOXPHENE EIA TEST (K943414)Diagnostic Reagents, Inc.1994-09-09
SYVA EMIT II PROPOXYPHENE ASSAY (K923873)Syva Co.1992-11-02
TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS (K912365)Abbott Laboratories1991-08-16
REVISED LABELING FOR SYVA PROPOXYPHENE ASSAYS (K874200)Syva Co.1987-10-28
EMIT D.A.U. PROPOXYPHENE ASSAY (K850920)Syva Co.1985-04-02

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Every clearance here is in the API, with alerts when new ones post.