510(k) K152227
K152227 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Cortisol II, Cortisol II CalSet". The FDA issued a decision of Substantially Equivalent on April 27, 2016. The device falls under product code JFT (Fluorometric, Cortisol), a Class II device regulated under 21 CFR 862.1205. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2016
- Date Received
- August 7, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorometric, Cortisol
- Device Class
- Class II
- Regulation Number
- 862.1205
- Review Panel
- CH
- Submission Type