510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN140039Unknown

NOVA View Automated Fluorescense Microscope

Inova Diagnostics, Inc., San Diego CA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN140039 is the FDA 510(k) clearance record for NOVA View Automated Fluorescense Microscope, a class II device, cleared for Inova Diagnostics, Inc. on under FDA product code PIV (Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use). FDA's definition for product code PIV reads: "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...". FDA records list 138 510(k) clearances for Inova Diagnostics, Inc., from to . As of , FDA records show no recalls naming DEN140039.

Clearance record

Decision date
Received
(115 days to decision)
Product code
PIV Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
Regulation
21 CFR 866.4750
Device class
Class II
Review panel
Immunology
Applicant
Inova Diagnostics, Inc. 9900 Old Grove Rd., San Diego CA
Third party review
No

Clearances, product code PIV

Trailing 12 months

FDA records hold no clearances under product code PIV in the trailing twelve months.

FDA records show no clearances under product code PIV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PIV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260