Cleared Traditional

QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,

K123593 · Inova Diagnostics, Inc. · Immunology
Apr 2013
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K123593 is an FDA 510(k) clearance for the QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,, a Anti-sm Antibody, Antigen And Control (Class II — Special Controls, product code LKP), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 17, 2013, 147 days after receiving the submission on November 21, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K123593 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2012
Decision Date April 17, 2013
Days to Decision 147 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

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