The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Four Liter Bag For Use W/redy 2000/dialert Systems.
| Device ID | K874607 |
| 510k Number | K874607 |
| Device Name: | FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | ORGANON TEKNIKA CORP. 800 CAPITOLA DR. Durham, NC 27713 |
| Contact | Sheldon Mazursky |
| Correspondent | Sheldon Mazursky ORGANON TEKNIKA CORP. 800 CAPITOLA DR. Durham, NC 27713 |
| Product Code | LKN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-09 |
| Decision Date | 1988-01-27 |