Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test Device
FDA 510(k) K040445 · ACON Laboratories, Inc.
510(k) numberK040445
Submission
- Device name
- Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test Device
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- February 20, 2004
- Decision date
- May 19, 2004
- 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 |
| 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 |
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Questions and answers
When was Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test Device cleared by the FDA?
Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test Device (K040445) received a 510(k) decision of Substantially Equivalent on May 19, 2004, 89 days after the submission was received.
What is the product code of K040445?
The FDA product code is JXN – Enzyme Immunoassay, Propoxyphene, a Class II (moderate risk) device regulated under 21 CFR 862.3700.