Cleared Traditional

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay

K181329 · Phadia AB · Immunology
Jun 2018
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K181329 is an FDA 510(k) clearance for the EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay, a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II — Special Controls, product code MSV), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on June 25, 2018, 38 days after receiving the submission on May 18, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K181329 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2018
Decision Date June 25, 2018
Days to Decision 38 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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