510(k) K220456
K220456 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys FT4 IV". The FDA issued a decision of Substantially Equivalent on April 7, 2023. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 2023
- Date Received
- February 17, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Free Thyroxine
- Device Class
- Class II
- Regulation Number
- 862.1695
- Review Panel
- CH
- Submission Type