510(k) K170864 ยท GGN Plasma, Coagulation Control
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
| Applicant | Maine Standards Company, LLC, Cumberland Foreside ME, US |
| Decision | Substantially Equivalent, Jun 21, 2017 |
| Received | Mar 23, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170864
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.