510(k) K160006 ยท MQL Media, Reproductive
Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit
| Applicant | Irvine Scientific, Santa Ana CA, US |
| Decision | Substantially Equivalent, May 4, 2016 |
| Received | Jan 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160006
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2021 | Fujifilm Irvine Scientific, Inc. Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst Open, Classified |
MQL | None listed |
| Sep 8, 2021 | Fujifilm Irvine Scientific, Inc. Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst Open, Classified |
MQL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.