Cleared Traditional

EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay

K182353 · Phadia AB · Immunology
Nov 2018
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K182353 is an FDA 510(k) clearance for the EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on November 27, 2018, 90 days after receiving the submission on August 29, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K182353 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2018
Decision Date November 27, 2018
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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