510(k) K961706 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR
| Applicant | Fresenius USA, Inc., Walnut Creek CA, US |
| Decision | Substantially Equivalent, Jul 31, 1996 |
| Received | May 2, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961706
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2011 | Fresenius Kabi, LLC The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031.
Used f Terminated |
LKN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.