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NOVA View Automated Fluorescense Microscope

DEN140039 Class II Post-NSE
Decision Date
2015-04-09
Sponsor / Applicant
Inova Diagnostics, Inc.

Technical Specification

510(k) Submission ID DEN140039
Product Code PIV
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.4750
Decision Date 2015-04-09
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

NOVA View Automated Fluorescense Microscope received FDA 510(k) clearance under submission number DEN140039, sponsored by Inova Diagnostics, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2015-04-09.

Classification & Regulation

This clearance is catalogued under FDA product code PIV and 21 CFR 866.4750, within the Immunology review panel as a Class II device.