The following data is part of a premarket notification filed by Siemens Healthcare Diagnostic Products Gmbh with the FDA for Automated Blood Coagulation Analyzer Cs-2500.
| Device ID | K172286 |
| 510k Number | K172286 |
| Device Name: | Automated Blood Coagulation Analyzer CS-2500 |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | Siemens Healthcare Diagnostic Products Gmbh Emil-von Behring Strasse 76 Marburg, DE 35041 |
| Contact | Nils Neumann |
| Correspondent | Nils Neumann Siemens Healthcare Diagnostic Products Gmbh Emil-von Behring Strasse 76 Marburg, DE 35041 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-28 |
| Decision Date | 2017-12-18 |
| Summary: | summary |