510(k) K981043 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL
| Applicant | Solution Technologies, South Ogden UT, US |
| Decision | Substantially Equivalent, May 26, 1998 |
| Received | Mar 20, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981043
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2012 | Fresenius Medical Care Holdings, Inc. Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (208.2 Liters)
Cat. No. 13-2251-0.
NaturaLyte liquid acid concentrate is formulated to be used with a three str Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.