510(k) K153150
K153150 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000". The FDA issued a decision of Substantially Equivalent on November 24, 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
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 2015
- Date Received
- November 2, 2015
- Clearance Type
- Special
- 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.