510(k) K865078 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
POWDERED BICARBONATE CONCENTRATE
| Applicant | Bicarbolyte Corp., Charlottesville VA, US |
| Decision | Substantially Equivalent, Mar 27, 1987 |
| Received | Dec 29, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K865078
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.