510(k) K012328 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER
| Applicant | Di-Chem, Inc., Champlin MN, US |
| Decision | Substantially Equivalent, Jan 18, 2002 |
| Received | Jul 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012328
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.