510(k) K171750 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Citric Complete Dry Citric Acid (45X)
| Applicant | Dimesol USA, LLC, Lewisberry PA, US |
| Decision | Substantially Equivalent, Mar 6, 2018 |
| Received | Jun 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171750
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2026 | Nipro Renal Soultions USA, Corporation Citric Complete Dry Citric Acid Concentrate
REF: DCA+200-25 & DCA+203-25 Open, Classified |
KPO | None listed |
| Jan 8, 2025 | Nipro Renal Soultions USA, Corporation Citric Complete - Dry Citric Acid Concentrate
Model Number: DCA+225-25 Open, Classified |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.