510(k) DEN140039
DEN140039 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "NOVA View Automated Fluorescense Microscope". The FDA issued a decision of De Novo Granted on April 9, 2015. The device falls under product code PIV (Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use), a Class II device regulated under 21 CFR 866.4750. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 9, 2015
- Date Received
- December 15, 2014
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
- Device Class
- Class II
- Regulation Number
- 866.4750
- Review Panel
- IM
- Submission Type
Automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescent technology. A trained operator must confirm all device generated results.