JOY
- Product code
- JOY
- Device name
- Device, Automated Cell-Locating
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.5260
- Medical specialty
- Hematology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 35 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243144 | 2025-06-27 | Scopio Labs , Ltd. | X100/X100HT with Full Field Peripheral Blood Smear (… | |
| K221309 | 2023-09-19 | Sigtuple Technologies Pvt. , Ltd. | AI100 with Shonit | FDA |
Official FDA classification page: JOY
Classification and pathway per current FDA publications. Data from openFDA (CC0).