510(k) K011665 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
BCT SYSTEM
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Aug 9, 2001 |
| Received | May 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011665
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2004 | Dade Behring , Inc. DispoSystem for BCT System.Model number OVFR03. 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.