The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Products Gmbh with the FDA for Sysmex Automated Blood Coagulation Analyzer Cs-5100.
| Device ID | K162420 |
| 510k Number | K162420 |
| Device Name: | Sysmex Automated Blood Coagulation Analyzer 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 | Petra Dissmann |
| Correspondent | Petra Dissmann SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH EMIL-VON-BEHRING STRASSE 76 Marburg, DE 35041 |
| Product Code | JPA |
| Subsequent Product Code | GGP |
| Subsequent Product Code | GJT |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-30 |
| Decision Date | 2016-12-12 |
| Summary: | summary |