Cleared Traditional

NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit

K161258 · Inova Diagnostics, Inc. · Immunology
Feb 2017
Decision
275d
Days
Class 2
Risk

About This 510(k) Submission

K161258 is an FDA 510(k) clearance for the NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on February 3, 2017, 275 days after receiving the submission on May 4, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K161258 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2016
Decision Date February 03, 2017
Days to Decision 275 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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