The following data is part of a De Novo classification by Inova Diagnostics, Inc. with the FDA for Nova View Automated Fluorescense Microscope.
| DeNovo ID | DEN140039 |
| Device Name: | NOVA View Automated Fluorescense Microscope |
| Classification | Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 Old Grove Road San Diego, CA 92131 |
| Contact | Gabriella Lakos |
| Product Code | PIV |
| CFR Regulation Number | 866.4750 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Immunology |
| Classification Advisory | Immunology |
| Type | Post-NSE |
| Date Received | 2014-12-15 |
| Decision Date | 2015-04-09 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950643708 | DEN140039 | 000 |
| 08426950621614 | DEN140039 | 000 |