Cleared Traditional

BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN

K033454 · Brahms Diagnostica, LLC · Immunology
Mar 2004
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K033454 is an FDA 510(k) clearance for the BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Brahms Diagnostica, LLC (Norcross, US). The FDA issued a Cleared decision on March 22, 2004, 144 days after receiving the submission on October 30, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K033454 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2003
Decision Date March 22, 2004
Days to Decision 144 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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