510(k) K142991 ยท MQL Media, Reproductive
LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA
| Applicant | Life Global Group, LLC, Gilford CT, US |
| Decision | Substantially Equivalent, Feb 17, 2015 |
| Received | Oct 16, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142991
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2024 | CooperSurgical, Inc. global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer. Open, Classified |
MQL | None listed |
| Apr 6, 2023 | CooperSurgical, Inc. Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060 Open, Classified |
MQL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.