The following data is part of a premarket notification filed by Bioview Ltd. with the FDA for Duet System.
| Device ID | K040591 |
| 510k Number | K040591 |
| Device Name: | DUET SYSTEM |
| Classification | Device, Automated Cell-locating |
| Applicant | BIOVIEW LTD. 12 HAMADA ST. Rehovot, IL 76703 |
| Contact | Dorit Winitz |
| Correspondent | Dorit Winitz BIOVIEW LTD. 12 HAMADA ST. Rehovot, IL 76703 |
| Product Code | JOY |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-08 |
| Decision Date | 2004-09-16 |
| Summary: | summary |