Cleared Traditional

ADVIA Centaur BR

K193489 · Siemens Healthcare Diagnostics, Inc. · Immunology
Feb 2020
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K193489 is an FDA 510(k) clearance for the ADVIA Centaur BR, a System, Test, Immunological, Antigen, Tumor (Class II — Special Controls, product code MOI), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on February 13, 2020, 58 days after receiving the submission on December 17, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K193489 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2019
Decision Date February 13, 2020
Days to Decision 58 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MOI — System, Test, Immunological, Antigen, Tumor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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