510(k) K092963 ยท MQL Media, Reproductive
GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3
| Applicant | Genx Intl., Inc., Gilford CT, US |
| Decision | Substantially Equivalent, Jan 14, 2011 |
| Received | Sep 25, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092963
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2022 | CooperSurgical, Inc. LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 Open, Classified |
MQL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.