510(k) K991341 ยท MQL Media, Reproductive
ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION
| Applicant | Irvine Scientific Sales Co., Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Jul 8, 1999 |
| Received | Apr 19, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991341
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2024 | Fujifilm Irvine Scientific, Inc. Sperm separation media are used to separate motile sperm from other constituents of semen. Open, Classified |
MQL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.