Cleared Traditional

QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA

K120817 · Inova Diagnostics, Inc. · Immunology
Feb 2013
Decision
344d
Days
Class 2
Risk

About This 510(k) Submission

K120817 is an FDA 510(k) clearance for the QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on February 26, 2013, 344 days after receiving the submission on March 19, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K120817 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2012
Decision Date February 26, 2013
Days to Decision 344 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MID — System, Test, Anticardiolipin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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