Cleared Traditional

ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB

K080092 · Roche Diagnostics Corp. · Immunology
Jul 2008
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K080092 is an FDA 510(k) clearance for the ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 28, 2008, 196 days after receiving the submission on January 14, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K080092 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2008
Decision Date July 28, 2008
Days to Decision 196 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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