510(k) K142723
K142723 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA Centaur Cortisol (COR) Assy". The FDA issued a decision of Substantially Equivalent on March 31, 2015. The device falls under product code JFT (Fluorometric, Cortisol), a Class II device regulated under 21 CFR 862.1205. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2015
- Date Received
- September 23, 2014
- 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