510(k) K083175 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Jan 26, 2009 |
| Received | Oct 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083175
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.