K230161 is an FDA 510(k) clearance for the ONLINE TDM Phenytoin - Free Phenytoin application. This device is classified as a Fluorescence Polarization Immunoassay, Diphenylhydantoin (free) (Class II - Special Controls, product code MOJ).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on March 30, 2023, 69 days after receiving the submission on January 20, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3350.
| 510(k) Number | K230161 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 2023 |
| Decision Date | March 30, 2023 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MOJ — Fluorescence Polarization Immunoassay, Diphenylhydantoin (free) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3350 |