Cleared Traditional

LIAISON Ferritin

K193650 · DiaSorin, Inc. · Immunology
Sep 2021
Decision
624d
Days
Class 2
Risk

About This 510(k) Submission

K193650 is an FDA 510(k) clearance for the LIAISON Ferritin, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on September 14, 2021, 624 days after receiving the submission on December 30, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number K193650 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2019
Decision Date September 14, 2021
Days to Decision 624 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DBF — Ferritin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5340

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