Cleared Traditional

EliA M2 Immunoassay

K181556 · Phadia AB · Immunology
Jul 2018
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K181556 is an FDA 510(k) clearance for the EliA M2 Immunoassay, a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBM), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on July 13, 2018, 30 days after receiving the submission on June 13, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5090.

Submission Details

510(k) Number K181556 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2018
Decision Date July 13, 2018
Days to Decision 30 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5090

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