The following data is part of a premarket notification filed by Rosys, Inc. with the FDA for Plato 3000.
| Device ID | K933088 |
| 510k Number | K933088 |
| Device Name: | PLATO 3000 |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | ROSYS, INC. 1309 VEALE RD. SUITE 21 Wilmington, DE 19810 |
| Contact | Lee Carter |
| Correspondent | Lee Carter ROSYS, INC. 1309 VEALE RD. SUITE 21 Wilmington, DE 19810 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-23 |
| Decision Date | 1994-02-25 |