Cleared Traditional

ADVIA CHEMISTRY FERRITIN (FRT) METHOD

K110736 · Siemens Healthcare Diagnostics, Inc. · Immunology
Aug 2011
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K110736 is an FDA 510(k) clearance for the ADVIA CHEMISTRY FERRITIN (FRT) METHOD, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on August 17, 2011, 154 days after receiving the submission on March 16, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number K110736 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2011
Decision Date August 17, 2011
Days to Decision 154 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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