510(k) K252431
K252431 is an FDA 510(k) premarket notification submitted by Roche Diagnostics GmbH for the device "Elecsys Calcitonin". The FDA issued a decision of Substantially Equivalent on April 24, 2026. The device falls under product code JKR (Radioimmunoassay, Calcitonin), a Class II device regulated under 21 CFR 862.1140. Roche Diagnostics GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2026
- Date Received
- August 1, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Calcitonin
- Device Class
- Class II
- Regulation Number
- 862.1140
- Review Panel
- CH
- Submission Type