Cleared Traditional

ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY

K112414 · Phadia US, Inc. · Immunology
Jun 2012
Decision
305d
Days
Class 2
Risk

About This 510(k) Submission

K112414 is an FDA 510(k) clearance for the ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY, a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II — Special Controls, product code MSV), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on June 22, 2012, 305 days after receiving the submission on August 22, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K112414 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2011
Decision Date June 22, 2012
Days to Decision 305 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MSV — System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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