Panels › Hematology › Product code JOY · Class 2
Device, Automated Cell-Locating
Regulation 864.5260
0510(k)s in 12 months (35 all time)
1recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in JOY
| Company | 510(k)s | Recalls |
|---|---|---|
| CellaVision AB | 7 | 2 |
| Triangle Biomedical Sciences, Inc. | 5 | 0 |
| Bioview , Ltd. | 4 | 0 |
| Ikonisys, Inc. | 3 | 0 |
| Scopio Labs , Ltd. | 3 | 0 |
| Accumed Intl., Inc. | 2 | 0 |
| Applied Imaging Corp. | 2 | 0 |
| Applied Spectral Imaging , Ltd. | 1 | 0 |
| Chroma Vision Medical Systems, Inc. | 1 | 0 |
| Geometric Data, Div. Smithkline Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2025 | Cellavision AB REF: CC286297 or BS737162
Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component. Open, Classified |
JOY | K092868 |
| May 7, 2018 | Roche Diagnostics Hematology cobas m 511 integrated hematology analyzer, Model Number 07261691190
Product Usage:
The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. Terminated |
JOY | K171655 |
| Dec 4, 2017 | Cellavision AB CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60
Product Usage:
The devices are automated cell-locating devices. The dev Open, Classified |
JOY | K033840 K092868 |
| May 2, 2016 | Leica Biosystems Richmond Inc. CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assis Terminated |
JOY | K042542 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.