The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Xprecia Stride Coagulation System, Xprecia System Pt Controls.
| Device ID | K151964 |
| 510k Number | K151964 |
| Device Name: | Xprecia Stride Coagulation System, Xprecia System PT Controls |
| Classification | Test, Time, Prothrombin |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 2 EDGEWATER DRIVE Norwood, MA 02062 |
| Contact | Noor Malki |
| Correspondent | Noor Malki SIEMENS HEALTHCARE DIAGNOSTICS 2 EDGEWATER DRIVE Norwood, MA 02062 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-16 |
| Decision Date | 2016-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414170794 | K151964 | 000 |
| 00630414034348 | K151964 | 000 |
| 00630414025148 | K151964 | 000 |
| 09360136000055 | K151964 | 000 |