K112427 is an FDA 510(k) clearance for the BICARB MIXING AND DISTRIBUTION SYSTEM. This device is classified as a Tank, Holding, Dialysis (Class II - Special Controls, product code FIN).
Submitted by Isopure, Corp. (Simpsonville, US). The FDA issued a Cleared decision on January 26, 2012, 156 days after receiving the submission on August 23, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K112427 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2011 |
| Decision Date | January 26, 2012 |
| Days to Decision | 156 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIN - Tank, Holding, Dialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |