K912365 is an FDA 510(k) clearance for the TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS. This device is classified as a Enzyme Immunoassay, Propoxyphene (Class II - Special Controls, product code JXN).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 16, 1991, 79 days after receiving the submission on May 29, 1991.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3700.
| 510(k) Number | K912365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1991 |
| Decision Date | August 16, 1991 |
| Days to Decision | 79 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 |