Cleared Traditional

ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS

K052407 · Fisher Diagnostics · Immunology
Jul 2006
Decision
320d
Days
Class 2
Risk

About This 510(k) Submission

K052407 is an FDA 510(k) clearance for the ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Fisher Diagnostics (Middletown, US). The FDA issued a Cleared decision on July 18, 2006, 320 days after receiving the submission on September 1, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K052407 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2005
Decision Date July 18, 2006
Days to Decision 320 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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