The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Products Gmbh with the FDA for Sysmex Cs-5100.
| Device ID | K172333 |
| 510k Number | K172333 |
| Device Name: | Sysmex CS-5100 |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring Strasse 76 Marburg, DE 35041 |
| Contact | Donna Noeh |
| Correspondent | Donna Noeh Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring Strasse 76 Marburg, DE 35041 |
| Product Code | JPA |
| Subsequent Product Code | GGW |
| Subsequent Product Code | GIR |
| Subsequent Product Code | GJT |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-02 |
| Decision Date | 2017-10-31 |
| Summary: | summary |