The following data is part of a premarket notification filed by Rockwell Medical Technologies, Inc. with the FDA for Acidified Component Concentrates For Bicarbonate Dialysis Containing Di-acetate.
| Device ID | K023985 |
| 510k Number | K023985 |
| Device Name: | ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | ROCKWELL MEDICAL TECHNOLOGIES, INC. 30142 WIXOM RD. Wixom, MI 48393 |
| Contact | Gerry Fritz |
| Correspondent | Gerry Fritz ROCKWELL MEDICAL TECHNOLOGIES, INC. 30142 WIXOM RD. Wixom, MI 48393 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-02 |
| Decision Date | 2003-02-28 |
| Summary: | summary |