Elecsys FT4 IV— 510(k) K220456
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K220456 for Elecsys FT4 IV, Substantially Equivalent on 2023-04-07. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code CEC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1695
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code CEC
view allMore clearances from Roche Diagnostics
view allAdverse events under product code CEC
product code CEC- Malfunction
- 899
- Total
- 899
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.