Company ยท US
CellaVision AB
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2020. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
2recalls (1 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JOY | Device, Automated Cell-Locating | 9 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2020 | K200595 | CellaVision DC-1, CellaVision DC-1 PPA CellaVision AB, SE | JOY |
| Aug 1, 2017 | K171315 | Advanced RBC Application CellaVision AB, SE | JOY |
| Sep 16, 2011 | K102778 | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION CellaVision AB | JOY |
| Nov 20, 2009 | K092868 | CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 CellaVision AB | JOY |
| Dec 5, 2008 | K080595 | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION CellaVision AB | JOY |
| Feb 10, 2004 | K033840 | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER CellaVision AB | JOY |
| Mar 15, 2001 | K003301 | DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER CellaVision AB | JOY |
Latest recalls
| 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 |
| 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 |