The following data is part of a premarket notification filed by Siemens Healthcare Diagnostic Products Gmbh with the FDA for Sysmex Automated Blood Coagulation Analyzer Cs-5100.
Device ID | K150678 |
510k Number | K150678 |
Device Name: | Sysmex Automated Blood Coagulation Analyzer CS-5100 |
Classification | System, Multipurpose For In Vitro Coagulation Studies |
Applicant | Siemens Healthcare Diagnostic Products Gmbh EMIL-VON-BEHRING-STR. 76 Marburg, DE 35041 |
Contact | Donna Noeh |
Correspondent | Donna Noeh SIEMENS HEALTHCARE DISGNOSTICS 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 | 2015-03-16 |
Decision Date | 2016-01-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04987562425426 | K150678 | 000 |