K023795 is an FDA 510(k) clearance for the PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT). This device is classified as a Enzyme Immunoassay, Propoxyphene (Class II - Special Controls, product code JXN).
Submitted by Lin-Zhi International, Inc. (San Jose, US). The FDA issued a Cleared decision on January 21, 2003, 69 days after receiving the submission on November 13, 2002.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3700.
| 510(k) Number | K023795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2002 |
| Decision Date | January 21, 2003 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | JXN — Enzyme Immunoassay, Propoxyphene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3700 |