510(k) K033840 ยท JOY Device, Automated Cell-Locating
CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
| Applicant | CellaVision AB, Minneapolis, MN, US |
| Decision | Substantially Equivalent, Feb 10, 2004 |
| Received | Dec 10, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033840
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.