K201301 is an FDA 510(k) clearance for the X100 with Full Field Peripheral Blood Smear (PBS) Application. This device is classified as a Device, Automated Cell-locating (Class II - Special Controls, product code JOY).
Submitted by Scopio Labs , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on October 2, 2020, 140 days after receiving the submission on May 15, 2020.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5260.
| 510(k) Number | K201301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2020 |
| Decision Date | October 02, 2020 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JOY - Device, Automated Cell-locating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5260 |