K030835 is an FDA 510(k) clearance for the 'RAPID ONE' - PROPOXYPHENE TEST. This device is classified as a Enzyme Immunoassay, Propoxyphene (Class II - Special Controls, product code JXN).
Submitted by American Bio Medica Corp. (Columbia, US). The FDA issued a Cleared decision on May 22, 2003, 66 days after receiving the submission on March 17, 2003.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3700.
| 510(k) Number | K030835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2003 |
| Decision Date | May 22, 2003 |
| Days to Decision | 66 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 |