The following data is part of a premarket notification filed by Keithley Development Co. with the FDA for Keithley Lymphocyte Depletion Cart.
| Device ID | K801899 |
| 510k Number | K801899 |
| Device Name: | KEITHLEY LYMPHOCYTE DEPLETION CART |
| Classification | Container, Transport, Kidney |
| Applicant | KEITHLEY DEVELOPMENT CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KDK |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-08 |
| Decision Date | 1980-09-26 |