Cleared Traditional

QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS

K141210 · Inova Diagnostics, Inc. · Immunology
Jan 2015
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K141210 is an FDA 510(k) clearance for the QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on January 29, 2015, 265 days after receiving the submission on May 9, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K141210 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2014
Decision Date January 29, 2015
Days to Decision 265 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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