510(k) K181461 · MQK Labware, Assisted Reproduction
Rapid-i Kit
| Applicant | Vitrolife Sweden AB, Västra Frölunda, SE |
| Decision | Substantially Equivalent, Jan 4, 2019 |
| Received | Jun 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181461
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.