FDA Product Code
FDA Product Code MOJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Toxicology
- 21 CFR Citation
- 862.3350
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230161 | ONLINE TDM Phenytoin - Free Phenytoin application | Roche Diagnostics | 2023-03-30 | Traditional | PDF ↗ |
| K952555 | COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS | Roche Diagnostic Systems, Inc. | 1995-07-31 | Traditional | PDF ↗ |
| K950280 | TDX(R)/TDXFLX(R) FREE PHENYTOIN II | Abbott Laboratories | 1995-05-02 | Traditional | PDF ↗ |
Product code MOJ · Class II · Clinical Toxicology. Data: openFDA.