510(k) K170960
K170960 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "CoaguChek Vantus System". The FDA issued a decision of Substantially Equivalent on December 25, 2017. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 25, 2017
- Date Received
- March 31, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Time, Prothrombin
- Device Class
- Class II
- Regulation Number
- 864.7750
- Review Panel
- HE
- Submission Type