Cleared Traditional

AESKULISA GLIA A AND AESKULISA GLIA G

K052439 · Aesku Diagnostics · Immunology
Feb 2006
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K052439 is an FDA 510(k) clearance for the AESKULISA GLIA A AND AESKULISA GLIA G, a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by Aesku Diagnostics (Miami, US). The FDA issued a Cleared decision on February 7, 2006, 154 days after receiving the submission on September 6, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K052439 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2005
Decision Date February 07, 2006
Days to Decision 154 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

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

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