K935375 is an FDA 510(k) clearance for the AXSYM PHENYTOIN ASSAY. 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 June 21, 1994, 225 days after receiving the submission on November 8, 1993.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3350.
| 510(k) Number | K935375 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 1993 |
| Decision Date | June 21, 1994 |
| Days to Decision | 225 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 |