510(k) K230161
K230161 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ONLINE TDM Phenytoin - Free Phenytoin application". The FDA issued a decision of Substantially Equivalent on March 30, 2023. The device falls under product code MOJ (Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)), a Class II device regulated under 21 CFR 862.3350. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2023
- Date Received
- January 20, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
- Device Class
- Class II
- Regulation Number
- 862.3350
- Review Panel
- TX
- Submission Type