510(k) K042542 ยท NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
CYTOVISION FOR CEP XY
| Applicant | Applied Imaging Corp., San Jose CA, US |
| Decision | Substantially Equivalent, Jan 10, 2005 |
| Received | Sep 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042542
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2016 | Leica Biosystems Richmond Inc. CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assis Terminated |
JOY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.