Cleared Traditional

QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls

K152013 · Inova Diagnostics, Inc. · Immunology
Apr 2016
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K152013 is an FDA 510(k) clearance for the QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls, a Anti-dna Antibody, Antigen And Control (Class II — Special Controls, product code LSW), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 11, 2016, 265 days after receiving the submission on July 21, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K152013 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2015
Decision Date April 11, 2016
Days to Decision 265 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LSW — Anti-dna Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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