JXN — Enzyme Immunoassay, Propoxyphene Class II
FDA Device Classification
Classification Details
- Product Code
- JXN
- Device Class
- Class II
- Regulation Number
- 862.3700
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K152495 | guangzhou wondfo biotech co | Wondfo Propoxyphene Urine Test | November 23, 2015 |
| K122752 | branan medical | FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX D | January 30, 2013 |
| K111363 | medica | PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL | December 6, 2011 |
| K043303 | roche diagnostics | ONLINE DAT PROPOXYPHENE PLUS | March 11, 2005 |
| K040445 | acon laboratories | ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DE | May 19, 2004 |
| K030835 | american bio medica | 'RAPID ONE' - PROPOXYPHENE TEST | May 22, 2003 |
| K023795 | lin-zhi international | PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST | January 21, 2003 |
| K022915 | alfa scientific designs | INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST | November 29, 2002 |
| K020787 | medtox diagnostics | VERDICT-II PROPOXYPHENE | May 2, 2002 |
| K013100 | abbott laboratories | PROPOXYPHENE | March 20, 2002 |
| K011163 | syva co., dade behring | MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 | May 10, 2001 |
| K993981 | syva | SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL | February 1, 2000 |
| K983700 | roche diagnostic systems | MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE | December 11, 1998 |
| K955675 | beckman instruments | SYNCHRON SYSTEMS PROPOXYPHENE REAGENT | February 9, 1996 |
| K951133 | microgenics | CEDIA DAU PROPOXYPHENE ASSAY | May 2, 1995 |
| K944372 | solarcare | STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA | February 8, 1995 |
| K945195 | roche diagnostic systems | ABUSCREEN ONLINE PROPOXPHENE | December 9, 1994 |
| K943414 | diagnostic reagents | PROPOXPHENE EIA TEST | September 9, 1994 |
| K923873 | syva | SYVA EMIT II PROPOXYPHENE ASSAY | November 2, 1992 |
| K912365 | abbott laboratories | TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS | August 16, 1991 |