Panels › Clinical Toxicology › Product code MOJ · Class 2
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
Regulation 862.3350
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MOJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Laboratories | 1 | 0 |
| Roche Diagnostic Systems, Inc. | 1 | 0 |
| Roche Diagnostics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 30, 2023 | K230161 | ONLINE TDM Phenytoin - Free Phenytoin application Roche Diagnostics | MOJ |
| Jul 31, 1995 | K952555 | COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS Roche Diagnostic Systems, Inc. | MOJ |
| May 2, 1995 | K950280 | TDX(R)/TDXFLX(R) FREE PHENYTOIN II Abbott Laboratories | MOJ |
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