K946328 is an FDA 510(k) clearance for the TDX(R)/TDXFLX(R) PHENYTOIN II. This device is classified as a Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) (Class II - Special Controls, product code LGR).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 28, 1995, 89 days after receiving the submission on December 29, 1994.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3350.
| 510(k) Number | K946328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1994 |
| Decision Date | March 28, 1995 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LGR — Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3350 |