510(k) K112644 ยท MQK Labware, Assisted Reproduction
SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
| Applicant | Lotus Bio, Ltd., Pawtucket RI, US |
| Decision | Substantially Equivalent, Dec 19, 2012 |
| Received | Sep 12, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112644
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.