510(k) K172197 · MQL Media, Reproductive
SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS
| Applicant | Origio A/S, Måløv, DK |
| Decision | Substantially Equivalent, Oct 13, 2017 |
| Received | Jul 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172197
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.