Propoxyphene
FDA 510(k) K013100 · Abbott Laboratories
510(k) numberK013100
Submission
- Device name
- Propoxyphene
- Applicant
- Abbott Laboratories
Irving, TX, US - Received
- September 17, 2001
- Decision date
- March 20, 2002
- 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 |
| K043303 | Online Dat Propoxyphene PlusJXN · Traditional | Roche Diagnostics Corp. | 03/11/2005SE |
| 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 |
| K011163 | Modification to the Emit II Plus Propoxyphene Assay, Model OSR9G229JXN · Special | Syva Co., Dade Behring, Inc. | 05/10/2001SE |
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Questions and answers
When was Propoxyphene cleared by the FDA?
Propoxyphene (K013100) received a 510(k) decision of Substantially Equivalent on March 20, 2002, 184 days after the submission was received.
What is the product code of K013100?
The FDA product code is JXN – Enzyme Immunoassay, Propoxyphene, a Class II (moderate risk) device regulated under 21 CFR 862.3700.