510(k) K090105 ยท GGW Test, Time, Partial Thromboplastin
LUPOTEK KCT
| Applicant | R2 Diagnostics, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Dec 30, 2010 |
| Received | Jan 15, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090105
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.