The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Redy 2000.
| Device ID | K882428 |
| 510k Number | K882428 |
| Device Name: | REDY 2000 |
| Classification | System, Dialysate Delivery, Sorbent Regenerated |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | Sheldon Mazursky |
| Correspondent | Sheldon Mazursky ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | FKT |
| CFR Regulation Number | 876.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-13 |
| Decision Date | 1988-10-25 |