MOJ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3350
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
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Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| ONLINE TDM Phenytoin - Free Phenytoin application (K230161) | Roche Diagnostics | 2023-03-30 | + Add |
| COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS (K952555) | Roche Diagnostic Systems, Inc. | 1995-07-31 | + Add |
| TDX(R)/TDXFLX(R) FREE PHENYTOIN II (K950280) | Abbott Laboratories | 1995-05-02 | + Add |
Track MOJ automatically
Every clearance here is in the API, with alerts when new ones post.