Cleared Traditional

QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS

K141328 · Inova Diagnostics, Inc. · Immunology
Feb 2015
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K141328 is an FDA 510(k) clearance for the QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 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 February 12, 2015, 267 days after receiving the submission on May 21, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K141328 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2014
Decision Date February 12, 2015
Days to Decision 267 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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