Cleared Traditional

EliA SymphonyS Immunoassay

K190710 · Phadia AB · Immunology
Nov 2019
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K190710 is an FDA 510(k) clearance for the EliA SymphonyS Immunoassay, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on November 29, 2019, 255 days after receiving the submission on March 19, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K190710 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2019
Decision Date November 29, 2019
Days to Decision 255 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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