510(k) K821304 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
CENTRALYTE BICARBONATE CONCENTRATE
| Applicant | Erika, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, May 18, 1982 |
| Received | May 4, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821304
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.