510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K901595Substantially Equivalent

Nova Lite(tm) Ana Mk

Inova Diagnostics, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901595 is the FDA 510(k) clearance record for NOVA LITE(TM) ANA MK, a class II device, cleared for Inova Diagnostics, Inc. on under FDA product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control). FDA records list 138 510(k) clearances for Inova Diagnostics, Inc., from to . As of , FDA records show no recalls naming K901595.

Clearance record

Decision date
Received
(21 days to decision)
Product code
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Inova Diagnostics, Inc. 10451 Roselle St., San Diego CA
Third party review
No

Clearances, product code DHN

Trailing 12 months

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

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