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 |