510(k) K151964
K151964 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "Xprecia Stride Coagulation System, Xprecia System PT Controls". The FDA issued a decision of Substantially Equivalent on September 30, 2016. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 2016
- Date Received
- July 16, 2015
- 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