510(k) K082631 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
THROMBO TEK PSE, MODEL 90-480
| Applicant | R2 Diagnostics, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Dec 17, 2008 |
| Received | Sep 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082631
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.