The following data is part of a premarket notification filed by Di-chem, Inc. with the FDA for Citryte.
| Device ID | K171015 |
| 510k Number | K171015 |
| Device Name: | Citryte |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | Di-Chem, Inc. 12297 Ensign Avenue North Champlin, MN 55316 |
| Contact | Keith Buchholz |
| Correspondent | Keith Buchholz Di-Chem, Inc. 12297 Ensign Avenue North Champlin, MN 55316 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-04 |
| Decision Date | 2017-10-13 |
| Summary: | summary |