510(k) K043519 ยท NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
ARIOL HER-2/NEU FISH
| Applicant | Applied Imaging Corp., San Jose CA, US |
| Decision | Substantially Equivalent, Apr 25, 2005 |
| Received | Dec 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043519
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2016 | Leica Biosystems Richmond Inc. Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of Terminated |
NQN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.