Cleared Traditional

NOVA Lite DAPI ANA Kit

K150155 · Inova Diagnostics, Inc. · Immunology

Apr 2015

Decision

75d

Days

Class 2

Risk

About This 510(k) Submission

K150155 is an FDA 510(k) clearance for the NOVA Lite DAPI ANA Kit, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 8, 2015, 75 days after receiving the submission on January 23, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K150155 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 2015
Decision Date	April 08, 2015
Days to Decision	75 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5100