Cleared Traditional

BRAHMS DIAGNOSTICA LUMITEST ANTI-TG

K000286 · Brahms Diagnostica, LLC · Immunology
Mar 2000
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K000286 is an FDA 510(k) clearance for the BRAHMS DIAGNOSTICA LUMITEST ANTI-TG, 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 17, 2000, 46 days after receiving the submission on January 31, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K000286 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2000
Decision Date March 17, 2000
Days to Decision 46 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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