K012547 is an FDA 510(k) clearance for the HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION. This device is classified as a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II - Special Controls, product code KPO).
Submitted by Di-Chem, Inc. (Champlin, US). The FDA issued a Cleared decision on January 18, 2002, 164 days after receiving the submission on August 7, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K012547 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2001 |
| Decision Date | January 18, 2002 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KPO - Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |