JOY — Device, Automated Cell-Locating Class II
FDA product code JOY covers "Device, Automated Cell-Locating", a Class II medical device regulated under 21 CFR 864.5260. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JOY
- Device Class
- Class II
- Regulation Number
- 864.5260
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243144 | scopio labs | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | June 27, 2025 |
| K221309 | sigtuple technologies pvt. | AI100 with Shonit | September 19, 2023 |
| K220013 | scopio labs | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Applicatio | May 3, 2022 |
| K200595 | cellavision | CellaVision DC-1, CellaVision DC-1 PPA | October 16, 2020 |
| K201301 | scopio labs | X100 with Full Field Peripheral Blood Smear (PBS) Application | October 2, 2020 |
| K182062 | sysmex america | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device | October 30, 2018 |
| K171315 | cellavision | Advanced RBC Application | August 1, 2017 |
| K102778 | cellavision | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION | September 16, 2011 |
| K092116 | medica | EASYCELL CELL LOCATOR | May 12, 2010 |
| K092868 | cellavision | CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 | November 20, 2009 |
| K080595 | cellavision | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION | December 5, 2008 |
| K071398 | applied spectral imaging | SCANVIEW, MODEL SC-300 | October 4, 2007 |
| K061602 | bioview | DUET SYSTEM | January 23, 2007 |
| K062755 | ikonisys | IKONISCOPE ONCOFISH BLADDER TEST SYSTEM | January 4, 2007 |
| K061392 | ikonisys | IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM | August 1, 2006 |
| K052577 | ikonisys | IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM | January 24, 2006 |
| K050840 | bioview | MODIFICATION TO DUET SYSTEM | August 16, 2005 |
| K040591 | bioview | DUET SYSTEM | September 16, 2004 |
| K033840 | cellavision | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER | February 10, 2004 |
| K030192 | bioview | DUET SYSTEM | August 20, 2003 |