JXN — Enzyme Immunoassay, Propoxyphene Class II
FDA product code JXN covers "Enzyme Immunoassay, Propoxyphene", a Class II medical device regulated under 21 CFR 862.3700. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |