The following data is part of a premarket notification filed by Standard Engineering with the FDA for Star I Workstation.
| Device ID | K942290 |
| 510k Number | K942290 |
| Device Name: | STAR I WORKSTATION |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | STANDARD ENGINEERING BERGENSTRAAT 49 3053 Haasrode, BE |
| Contact | Peter Van Praet |
| Correspondent | Peter Van Praet STANDARD ENGINEERING BERGENSTRAAT 49 3053 Haasrode, BE |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-11 |
| Decision Date | 1994-08-26 |