The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Centralyte Bicarbonate Concentrate.
| Device ID | K821304 |
| 510k Number | K821304 |
| Device Name: | CENTRALYTE BICARBONATE CONCENTRATE |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | ERIKA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-04 |
| Decision Date | 1982-05-18 |