The following data is part of a premarket notification filed by Bioview Ltd. with the FDA for Duet System.
| Device ID | K130775 |
| 510k Number | K130775 |
| Device Name: | DUET SYSTEM |
| Classification | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays |
| Applicant | BIOVIEW LTD. 25A SIRKIN ST. Kfar Saba, IL 44421 |
| Contact | Orly Maor |
| Correspondent | Orly Maor BIOVIEW LTD. 25A SIRKIN ST. Kfar Saba, IL 44421 |
| Product Code | NTH |
| CFR Regulation Number | 866.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-20 |
| Decision Date | 2014-05-09 |
| Summary: | summary |