K221309 is an FDA 510(k) clearance for the AI100 with Shonit. This device is classified as a Device, Automated Cell-locating (Class II - Special Controls, product code JOY).
Submitted by Sigtuple Technologies Pvt. , Ltd. (Bangalore, IN). The FDA issued a Cleared decision on September 19, 2023, 502 days after receiving the submission on May 5, 2022.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5260.
| 510(k) Number | K221309 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2022 |
| Decision Date | September 19, 2023 |
| Days to Decision | 502 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 |