CellaVision AB
CellaVision AB holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2020, with 2 FDA device recalls on record.
Top product codes for CellaVision AB
FDA recalls by CellaVision AB
- Z-0542-2026 — 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.
- Z-2184-2018 — 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 locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by CellaVision AB
- K200595 — CellaVision DC-1, CellaVision DC-1 PPA
- K171315 — Advanced RBC Application
- K102778 — CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
- K092868 — CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
- K080595 — CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
- K033840 — CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
- K003301 — DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.