MOJ — Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free) Class II
FDA product code MOJ covers "Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)", a Class II medical device regulated under 21 CFR 862.3350. Submissions are reviewed by the Clinical Toxicology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MOJ
- Device Class
- Class II
- Regulation Number
- 862.3350
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K230161 | roche diagnostics | ONLINE TDM Phenytoin - Free Phenytoin application | March 30, 2023 |
| K952555 | roche diagnostic systems | COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTR | July 31, 1995 |
| K950280 | abbott laboratories | TDX(R)/TDXFLX(R) FREE PHENYTOIN II | May 2, 1995 |