510(k) K013114 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
BCS SYSTEM
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Nov 9, 2001 |
| Received | Sep 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013114
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 19, 2016 | Siemens Healthcare Diagnostics, Inc. BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING CO Terminated |
JPA | None listed |
| Jun 26, 2012 | Siemens Healthcare Diagnostics, Inc. BCS(R) Behring Coagulation System, Device catalog No. OVIO03
Product Usage:
Multipurpose system for In Vitro coagulation studies Terminated |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.