Panels › Clinical Toxicology › Product code JXN · Class 2
Enzyme Immunoassay, Propoxyphene
Regulation 862.3700
0510(k)s in 12 months (22 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in JXN
| Company | 510(k)s | Recalls |
|---|---|---|
| Syva Co. | 4 | 0 |
| Abbott Laboratories | 2 | 0 |
| Roche Diagnostic Systems, Inc. | 2 | 0 |
| ACON Laboratories, Inc. | 1 | 0 |
| Alfa Scientific Designs, Inc. | 1 | 0 |
| American Bio Medica Corp. | 1 | 0 |
| Beckman Instruments, Inc. | 1 | 0 |
| Branan Medical Corp. | 1 | 0 |
| Diagnostic Reagents, Inc. | 1 | 0 |
| Express Diagnostics Int'l., Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 23, 2015 | K152495 | Wondfo Propoxyphene Urine Test Guangzhou Wondfo Biotech Co., Ltd., CN | JXN |
| Jan 30, 2013 | K122752 | FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD Branan Medical Corp. | JXN |
| Dec 6, 2011 | K111363 | PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL Medica Corp. | JXN |
| Mar 11, 2005 | K043303 | ONLINE DAT PROPOXYPHENE PLUS Roche Diagnostics Corp. | JXN |
| May 19, 2004 | K040445 | ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE ACON Laboratories, Inc. | JXN |
| May 22, 2003 | K030835 | 'RAPID ONE' - PROPOXYPHENE TEST American Bio Medica Corp. | JXN |
| Jan 21, 2003 | K023795 | PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) Lin-Zhi International, Inc. | JXN |
| Nov 29, 2002 | K022915 | INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST Alfa Scientific Designs, Inc. | JXN |
| May 2, 2002 | K020787 | VERDICT-II PROPOXYPHENE Medtox Diagnostics, Inc. | JXN |
| Mar 20, 2002 | K013100 | PROPOXYPHENE Abbott Laboratories | JXN |
| May 10, 2001 | K011163 | MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 Syva Co., Dade Behring, Inc. | JXN |
| Feb 1, 2000 | K993981 | SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL Syva Co. | JXN |
| Dec 11, 1998 | K983700 | MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE Roche Diagnostic Systems, Inc. | JXN |
| Feb 9, 1996 | K955675 | SYNCHRON SYSTEMS PROPOXYPHENE REAGENT Beckman Instruments, Inc. | JXN |
| May 2, 1995 | K951133 | CEDIA DAU PROPOXYPHENE ASSAY Microgenics Corp. | JXN |
| Feb 8, 1995 | K944372 | STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA Solarcare, Inc. | JXN |
| Dec 9, 1994 | K945195 | ABUSCREEN ONLINE PROPOXPHENE Roche Diagnostic Systems, Inc. | JXN |
| Sep 9, 1994 | K943414 | PROPOXPHENE EIA TEST Diagnostic Reagents, Inc. | JXN |
| Nov 2, 1992 | K923873 | SYVA EMIT II PROPOXYPHENE ASSAY Syva Co. | JXN |
| Aug 16, 1991 | K912365 | TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS Abbott Laboratories | JXN |
| Oct 28, 1987 | K874200 | REVISED LABELING FOR SYVA PROPOXYPHENE ASSAYS Syva Co. | JXN |
| Apr 2, 1985 | K850920 | EMIT D.A.U. PROPOXYPHENE ASSAY Syva Co. | JXN |
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