Cleared Traditional

IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material

K152061 · Siemens Healthcare Diagnostics, Inc. · Immunology
Mar 2016
Decision
223d
Days
Class 2
Risk

About This 510(k) Submission

K152061 is an FDA 510(k) clearance for the IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on March 3, 2016, 223 days after receiving the submission on July 24, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K152061 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2015
Decision Date March 03, 2016
Days to Decision 223 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JZO — System, Test, Thyroid Autoantibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5870

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