K823103 is an FDA 510(k) clearance for the DIALYSATE ADDITIVES-POWDER/LIQUID. 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. (Mchenry, US). The FDA issued a Cleared decision on November 17, 1982, 28 days after receiving the submission on October 20, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K823103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1982 |
| Decision Date | November 17, 1982 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | - |
| Product Code | KPO - Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |