Cleared Traditional

GLIADIN IGA AND GLIADIN LGA

K113377 · Grifols USA, LLC · Immunology
Dec 2012
Decision
394d
Days
Class 2
Risk

About This 510(k) Submission

K113377 is an FDA 510(k) clearance for the GLIADIN IGA AND GLIADIN LGA, a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by Grifols USA, LLC (Los Angeles, US). The FDA issued a Cleared decision on December 14, 2012, 394 days after receiving the submission on November 16, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K113377 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2011
Decision Date December 14, 2012
Days to Decision 394 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MST — Antibodies, Gliadin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5750

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