510(k) K162705 · GGN Plasma, Coagulation Control
VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
| Applicant | Maine Standards Company, LLC, Cumberland Foreside ME, US |
| Decision | Substantially Equivalent, Jan 5, 2017 |
| Received | Sep 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162705
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.