510(k) K163498 ยท GGN Plasma, Coagulation Control
VALIDATE Heparin Calibration Verification/Linearity Test Kit
| Applicant | Maine Standards Company, LLC, Cumberland Foreside ME, US |
| Decision | Substantially Equivalent, Mar 16, 2017 |
| Received | Dec 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163498
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.