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 |