510(k) K171605
K171605 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys CA 15-3 II". The FDA issued a decision of Substantially Equivalent on February 20, 2018. The device falls under product code MOI (System, Test, Immunological, Antigen, Tumor), a Class II device regulated under 21 CFR 866.6010. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 2018
- Date Received
- June 1, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Immunological, Antigen, Tumor
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type