Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of MindrayLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list CellaVision AB with 7 510(k) clearances, 6 AI-enabled devices and 2 device recalls. The most recent is a device recall dated Oct 8, 2025: REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conj….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 8, 2025 | REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcodClass II · Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misa | Device recalls |
| Oct 16, 2020 | CellaVision DC-1, CellaVision DC-1 PPAK200595 · JOY | 510(k) clearances |
| Oct 16, 2020 | CellaVision DC-1, CellaVision DC-1 PPAK200595 · Hematology | AI-enabled devices |
| Dec 4, 2017 | CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product UClass II · A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. | Device recalls |
| Aug 1, 2017 | Advanced RBC ApplicationK171315 · JOY | 510(k) clearances |
| Aug 1, 2017 | Advanced RBC ApplicationK171315 · Hematology | AI-enabled devices |
| Sep 16, 2011 | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTIONK102778 · JOY | 510(k) clearances |
| Sep 16, 2011 | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTIONK102778 · Hematology | AI-enabled devices |
| Nov 20, 2009 | CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127K092868 · JOY | 510(k) clearances |
| Dec 5, 2008 | CELLAVISION DM96 WITH THE BODY FLUID APPLICATIONK080595 · JOY | 510(k) clearances |
| Dec 5, 2008 | CELLAVISION DM96 WITH THE BODY FLUID APPLICATIONK080595 · Hematology | AI-enabled devices |
| Feb 10, 2004 | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZERK033840 · JOY | 510(k) clearances |
| Feb 10, 2004 | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZERK033840 · Hematology | AI-enabled devices |
| Mar 15, 2001 | DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZERK003301 · JOY | 510(k) clearances |
| Mar 15, 2001 | DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZERK003301 · Hematology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
