510(k) K102851 ยท GJT Plasma, Coagulation Factor Deficient
NOFACT VIII
| Applicant | R2 Diagnostics, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Dec 19, 2011 |
| Received | Sep 29, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102851
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.