Cleared Traditional

QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls

K152635 · Inova Diagnostics, Inc. · Immunology
Jun 2016
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K152635 is an FDA 510(k) clearance for the QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 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 June 1, 2016, 260 days after receiving the submission on September 15, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K152635 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2015
Decision Date June 01, 2016
Days to Decision 260 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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