The following data is part of a premarket notification filed by Tecan U.s., Ltd. with the FDA for Tecan Robotic Sample Processor(rsp) #500.
| Device ID | K854406 |
| 510k Number | K854406 |
| Device Name: | TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500 |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | TECAN U.S., LTD. P.O. BOX 8101 Hillsborough, NC 27278 |
| Contact | Werner Martin |
| Correspondent | Werner Martin TECAN U.S., LTD. P.O. BOX 8101 Hillsborough, NC 27278 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-01 |
| Decision Date | 1986-02-10 |