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-2100i.
| Device ID | K151259 |
| 510k Number | K151259 |
| Device Name: | Sysmex Automated Blood Coagulation Analyzer CS-2100i |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH EMIL-VON BEHRING-STR. 76 Marburg, DE 35041 |
| Contact | Nils Neumann |
| Correspondent | Nils Neumann SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH EMIL-VON BEHRING-STR. 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 | 2015-05-12 |
| Decision Date | 2016-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987562433735 | K151259 | 000 |
| 04987562409471 | K151259 | 000 |