510(k) K043303
- Device
- ONLINE DAT PROPOXYPHENE PLUS
- Applicant
- ROCHE DIAGNOSTICS CORP.
- 510(k) number
- K043303
- Product code
- JXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-03-11
- Date received
- 2004-11-30
- Regulation
- 862.3700
- Classification name
- Enzyme Immunoassay, Propoxyphene
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KERWIN KAUFMAN
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3010800486
- 3012725363
- 3006198300
- 3006048451
- 1063851
- 3005360469
- 3003795116
- 3013684380
- 3036649420
- 3011522054
- 3005641941
- 3007606081
- 2030861
- 3004987297
- 3009585529
- 2050012
- 1050155
- 2090110
- 3005333358
- 3013679502
- 9610529
- 2432235
- 3007126977
- 3010934853
- 3017904598
- 2060833
- 2915274
- 1649661
- 3010220539
- 3010939897
- 3008852306
- 2517506
- 1827821
- 3021186226
- 3010852191
- 3030648160
- 3011559327
- 3008517993
- 3008987086
- 3004175381
- 3009238284
- 2050010
- 3005984081
- 3003917514
- 3004635103
- 3031697086
- 9610126
- 2027969
- 2030633
- 1220972
- 3009212837
- 3003610499
- 3034694973
- 3023322455
Source Documents#
Other 510(k) Records For Product Code JXN #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary