Online Dat Propoxyphene Plus
FDA 510(k) K043303 · Roche Diagnostics Corp.
510(k) numberK043303
Submission
- Device name
- Online Dat Propoxyphene Plus
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- November 30, 2004
- Decision date
- March 11, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JXN – Enzyme Immunoassay, Propoxyphene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3700
- Specialty
- Clinical Toxicology
Other 510(k)s with product code JXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152495 | Wondfo Propoxyphene Urine TestJXN · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 11/23/2015SE |
| K122752 | Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug…JXN · Traditional | Branan Medical Corp. | 01/30/2013SE |
| K111363 | PPX Reagent, PPX Calibrators, PPX QC MaterialJXN · Traditional | Medica Corp. | 12/06/2011SE |
| K040445 | Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test DeviceJXN · Traditional | ACON Laboratories, Inc. | 05/19/2004SE |
| K030835 | 'Rapid One' - Propoxyphene TestJXN · Traditional | American Bio Medica Corp. | 05/22/2003SE |
| K023795 | Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000 Test Kit)JXN · Traditional | Lin-Zhi International, Inc. | 01/21/2003SE |
| K022915 | Instant-View Propoxyphene (PPX) Urine TestJXN · Traditional | Alfa Scientific Designs, Inc. | 11/29/2002SE |
| K020787 | Verdict-Ii PropoxypheneJXN · Traditional | Medtox Diagnostics, Inc. | 05/02/2002SE |
| K013100 | PropoxypheneJXN · Traditional | Abbott Laboratories | 03/20/2002SE |
| K011163 | Modification to the Emit II Plus Propoxyphene Assay, Model OSR9G229JXN · Special | Syva Co., Dade Behring, Inc. | 05/10/2001SE |
More from Syva Co., Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | 06/12/2026SE |
| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was Online Dat Propoxyphene Plus cleared by the FDA?
Online Dat Propoxyphene Plus (K043303) received a 510(k) decision of Substantially Equivalent on March 11, 2005, 101 days after the submission was received.
What is the product code of K043303?
The FDA product code is JXN – Enzyme Immunoassay, Propoxyphene, a Class II (moderate risk) device regulated under 21 CFR 862.3700.