K880102 is an FDA 510(k) clearance for the BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS. This device is classified as a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II - Special Controls, product code KPO).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on May 26, 1988, 135 days after receiving the submission on January 12, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K880102 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 1988 |
| Decision Date | May 26, 1988 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KPO — Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |