510(k) K163215 ยท KHG Whole Blood Hemoglobin Determination
AnemoCheck
| Applicant | Sanguina, LLC, Atlanta GA, US |
| Decision | Substantially Equivalent, Sep 13, 2017 |
| Received | Nov 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163215
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.