510(k) K052457 ยท MQK Labware, Assisted Reproduction
PICSI SPERM SELECTION DEVICE
| Applicant | Biocoat, Inc., Horsham PA, US |
| Decision | Substantially Equivalent, Apr 13, 2006 |
| Received | Sep 7, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052457
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.