K221309
- 510(k) number
- K221309
- Device name
- AI100 with Shonit
- Applicant
- Sigtuple Technologies Pvt. , Ltd. IN
- Product code
- JOY — Device, Automated Cell-Locating
- Decision date
- 2023-09-19
- Date received
- 2022-05-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
510(k) Summary (official FDA PDF): K221309.pdf
Official FDA record: K221309
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.