K193155 is an FDA 510(k) clearance for the Nipro Dry Complete Dry Acid Concentrate for Hemodialysis. This device is classified as a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II - Special Controls, product code KPO).
Submitted by Nipro Renal Solutions USA, Corp. (Lewisberry, US). The FDA issued a Cleared decision on November 25, 2020, 377 days after receiving the submission on November 14, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K193155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2019 |
| Decision Date | November 25, 2020 |
| Days to Decision | 377 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPO - Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |