510(k) K023985 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE
| Applicant | Rockwell Medical Technologies, Inc., Wixom MI, US |
| Decision | Substantially Equivalent, Feb 28, 2003 |
| Received | Dec 2, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023985
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.