510(k) K092868 ยท JOY Device, Automated Cell-Locating
CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
| Applicant | CellaVision AB, Fridley MN, US |
| Decision | Substantially Equivalent, Nov 20, 2009 |
| Received | Sep 18, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092868
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.