510(k) K970431 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
BEHRING COAGULATION SYSTEM
| Applicant | Behring Diagnostics, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, May 5, 1997 |
| Received | Feb 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970431
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2021 | Siemens Healthcare Diagnostics, Inc. BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform qua Terminated |
JPA | None listed |
| Feb 19, 2016 | Siemens Healthcare Diagnostics, Inc. BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 104618 Terminated |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.