The following data is part of a premarket notification filed by Rockwell Medical with the FDA for Rockwell Medical Citrapure Acid Concetrate.
| Device ID | K160847 |
| 510k Number | K160847 |
| Device Name: | Rockwell Medical CitraPure Acid Concetrate |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | ROCKWELL MEDICAL 30142 WIXOM ROAD Wixom, MI 48393 |
| Contact | Robert Chioini |
| Correspondent | Robert Chioini ROCKWELL MEDICAL 30142 WIXOM ROAD 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 | 2016-03-28 |
| Decision Date | 2016-10-20 |
| Summary: | summary |