Cleared Traditional

Atellica IM Ferritin Assay

K171642 · Siemens Healthcare Diagnostics, Inc. · Immunology
Aug 2017
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K171642 is an FDA 510(k) clearance for the Atellica IM Ferritin Assay, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on August 31, 2017, 90 days after receiving the submission on June 2, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number K171642 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2017
Decision Date August 31, 2017
Days to Decision 90 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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