510(k) K071265 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
SMARTCHECK INR SYSTEM
| Applicant | Inverness Medical Innovations, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Nov 30, 2007 |
| Received | May 7, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071265
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.