Cleared Traditional

NOVA Lite DAPI dsDNA Crithidia luciliae Kit

K192916 · Inova Diagnostics, Inc. · Immunology
Dec 2020
Decision
423d
Days
Class 2
Risk

About This 510(k) Submission

K192916 is an FDA 510(k) clearance for the NOVA Lite DAPI dsDNA Crithidia luciliae Kit, a Anti-dna Indirect Immunofluorescent Solid Phase (Class II — Special Controls, product code KTL), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 11, 2020, 423 days after receiving the submission on October 15, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K192916 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2019
Decision Date December 11, 2020
Days to Decision 423 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code KTL — Anti-dna Indirect Immunofluorescent Solid Phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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