The following data is part of a premarket notification filed by Tecan U.s., Ltd. with the FDA for Robotic Sample Processor.
| Device ID | K912036 |
| 510k Number | K912036 |
| Device Name: | ROBOTIC SAMPLE PROCESSOR |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | TECAN U.S., LTD. 164 DIMMOCKS MILL RD. P.O. BOX 8101 Hillsborough, NC 27278 |
| Contact | David L Juranas |
| Correspondent | David L Juranas TECAN U.S., LTD. 164 DIMMOCKS MILL RD. 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 | 1991-05-08 |
| Decision Date | 1991-07-26 |