510(k) K991390 ยท MQL Media, Reproductive
1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI
| Applicant | Sage Biopharma, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 18, 2000 |
| Received | Apr 21, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991390
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2016 | CooperSurgical, Inc. Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017
SAGE In Vitro Fertilization, Inc.
A CooperSurgical Company
95 Corporate Drive
Trumb Terminated |
MQL | None listed |
| Sep 20, 2016 | CooperSurgical, Inc. Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium
Product Number: ART-8018
Intended for use in freezing embryos. This product is intended for thawing of embryos f Terminated |
MQL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.