Cleared Traditional

ADVIA Centaur Total IgE (tIgE)

K193493 · Siemens Healthcare Diagnostics, Inc. · Immunology
Jan 2020
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K193493 is an FDA 510(k) clearance for the ADVIA Centaur Total IgE (tIgE), a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on January 15, 2020, 29 days after receiving the submission on December 17, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K193493 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2019
Decision Date January 15, 2020
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DGC — Ige, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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