K874200 is an FDA 510(k) clearance for the REVISED LABELING FOR SYVA PROPOXYPHENE ASSAYS. This device is classified as a Enzyme Immunoassay, Propoxyphene (Class II - Special Controls, product code JXN).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on October 28, 1987, 14 days after receiving the submission on October 14, 1987.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3700.
| 510(k) Number | K874200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1987 |
| Decision Date | October 28, 1987 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | JXN — Enzyme Immunoassay, Propoxyphene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3700 |