Cleared Traditional

ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR

K110874 · Siemens Healthcare Diagnostics, Inc. · Immunology
Jan 2012
Decision
297d
Days
Class 2
Risk

About This 510(k) Submission

K110874 is an FDA 510(k) clearance for the ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR, a System, Test, Beta-2-microglobulin Immunological (Class II — Special Controls, product code JZG), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on January 20, 2012, 297 days after receiving the submission on March 29, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.

Submission Details

510(k) Number K110874 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2011
Decision Date January 20, 2012
Days to Decision 297 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JZG — System, Test, Beta-2-microglobulin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5630

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