510(k) K031715 ยท NOT Microscope, Automated, Image Analysis, Operator Intervention
ARIOL HER-2/NEU IHC
| Applicant | Applied Imaging Corp., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jan 8, 2004 |
| Received | Jun 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031715
| 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.