510(k) DEN140039
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.