510(k) K191474 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Feb 24, 2020 |
| Received | Jun 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191474
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.