510(k) K180679 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)
| Applicant | Global Scientific Technologies, LLC, Greer SC, US |
| Decision | Substantially Equivalent, Dec 7, 2018 |
| Received | Mar 15, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180679
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.