Product code JXN
- Device name
- Enzyme Immunoassay, Propoxyphene
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3700
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152495 | Wondfo Propoxyphene Urine Test | Guangzhou Wondfo Biotech Co., Ltd. | 2015-11-23 |
| K122752 | FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD | Branan Medical Corp. | 2013-01-30 |
| 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 |
| K945195 | ABUSCREEN ONLINE PROPOXPHENE | Roche Diagnostic Systems, Inc. | 1994-12-09 |
| K943414 | PROPOXPHENE EIA TEST | Diagnostic Reagents, Inc. | 1994-09-09 |
| K923873 | SYVA EMIT II PROPOXYPHENE ASSAY | Syva Co. | 1992-11-02 |
| K912365 | TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS | Abbott Laboratories | 1991-08-16 |
| K874200 | REVISED LABELING FOR SYVA PROPOXYPHENE ASSAYS | Syva Co. | 1987-10-28 |
| K850920 | EMIT D.A.U. PROPOXYPHENE ASSAY | Syva Co. | 1985-04-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810173656733 | Healgen | Healgen Scientific Limited Liability Company | 2026-06-03 |
| 00810173656726 | Healgen | Healgen Scientific Limited Liability Company | 2026-06-03 |
| 00810173656788 | Healgen | Healgen Scientific Limited Liability Company | 2026-06-03 |
| 00810173656771 | Healgen | Healgen Scientific Limited Liability Company | 2026-06-03 |
| 00810173656764 | Healgen | Healgen Scientific Limited Liability Company | 2026-06-03 |
| 00810173656757 | Healgen | Healgen Scientific Limited Liability Company | 2026-06-03 |
| 00810173656740 | Healgen | Healgen Scientific Limited Liability Company | 2026-06-03 |
| 00810173656702 | Accurate | Healgen Scientific Limited Liability Company | 2026-06-02 |
| 07290006418326 | CHROMOSTREAK | SAVYON DIAGNOSTICS LTD | 2026-05-27 |
| 10694644100218 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
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| 10694644100195 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100188 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
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| 10694644100164 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100157 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100140 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100133 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100126 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100119 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100102 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100096 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100089 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100072 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100065 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100058 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100041 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100034 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100027 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100010 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |