The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Naturalyte Bicarbonate Concentrate-dry Pack.
| Device ID | K852310 |
| 510k Number | K852310 |
| Device Name: | NATURALYTE BICARBONATE CONCENTRATE-DRY PACK |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | ERIKA, INC. ONE ERIKA PLAZA Rockleigh, NJ 07647 |
| Contact | Del Donna |
| Correspondent | Del Donna ERIKA, INC. ONE ERIKA PLAZA Rockleigh, NJ 07647 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-29 |
| Decision Date | 1985-07-26 |