510(k) K143534
K143534 is an FDA 510(k) premarket notification submitted by Roche Professional Diagnostics for the device "Elecsys CA-125 II assay". The FDA issued a decision of Substantially Equivalent on August 6, 2015. The device falls under product code LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)), a Class II device regulated under 21 CFR 866.6010. Roche Professional Diagnostics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 2015
- Date Received
- December 12, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type