The following data is part of a premarket notification filed by Scopio Labs Ltd. with the FDA for X100 With Full Field Peripheral Blood Smear (pbs) Application.
| Device ID | K201301 |
| 510k Number | K201301 |
| Device Name: | X100 With Full Field Peripheral Blood Smear (PBS) Application |
| Classification | Device, Automated Cell-locating |
| Applicant | Scopio Labs LTD. 11 Tiomkin St., 2nd Floor Tel Aviv, IL 6578313 |
| Contact | Shahar Karny |
| Correspondent | Yarmela Pavlovic Manatt Health 1 Embarcadero Center, 30th Floor San Francisco, CA 94111 |
| Product Code | JOY |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-15 |
| Decision Date | 2020-10-02 |