Xprecia Stride Coagulation System, Xprecia System PT Controls
FDA 510(k) clearance K151964 · decided 2016-09-30
Clearance details
- K-number
- K151964
- Device name
- Xprecia Stride Coagulation System, Xprecia System PT Controls
- Applicant
- Siemens Healthcare Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2015-07-16
- Decision date
- 2016-09-30
- Days to decision
- 442 days
- Clearance type
- Traditional
- Product code
- GJS
- Device class
- 2
- Regulation number
- 864.7750
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Norowood, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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