Data / Medical devices / Sweden / Cellavision AB
Cellavision AB: FDA-registered device maker in LUND Skane, Sweden, 6 510(k) clearances
Cellavision AB is registered with the FDA (registration 3003630693) in LUND Skane, Sweden. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 16, 2020. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003630693
- Address
- Mobilvagen 12, LUND Skane, Sweden, SE-22362
- Owner or operator
- CellaVision AB (9043433)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 22, 2007
- Registered through
- 2026
- Brand names listed
- Automated Digital Cell Morphology Analyzer DI-60, CellaVision Body Fluid Application, CellaVision Body Fluid Application for DM1200, DM9600 and DI-60, CellaVision DC-1, CellaVision DC-1 PPA, CellaVision DM1200, CellaVision DM96, CellaVision DM96 and DM1200 with Advanced RBC Application and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Counter, Differential Cell | GKZ | 2 | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Device, Automated Cell-Locating | JOY | 2 | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Spinner, Slide, Automated | GKJ | 1 | Complaint file establishment, Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 16, 2020 | K200595 | CellaVision DC-1, CellaVision DC-1 PPA | JOY | Substantially Equivalent | CellaVision AB | accessdata.fda.gov |
| August 1, 2017 | K171315 | Advanced RBC Application | JOY | Substantially Equivalent | CellaVision AB | accessdata.fda.gov |
| September 16, 2011 | K102778 | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION | JOY | Substantially Equivalent | CellaVision AB | accessdata.fda.gov |
| November 20, 2009 | K092868 | CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 | JOY | Substantially Equivalent | CellaVision AB | accessdata.fda.gov |
| December 5, 2008 | K080595 | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION | JOY | Substantially Equivalent | CellaVision AB | accessdata.fda.gov |
| February 10, 2004 | K033840 | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER | JOY | Substantially Equivalent | CellaVision AB | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 8, 2025 | 97835 | Class II | Ongoing | 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. | Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results. | accessdata.fda.gov |
| December 4, 2017 | 80137 | Class II | Ongoing | 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 devices automatically lo | A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample. | accessdata.fda.gov |
Compare with other makers
- All makers of Counter, Differential Cell
- All makers of Device, Automated Cell-Locating
- All makers of Medical Device Data System
- All makers of Spinner, Slide, Automated
Updated November 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.