Cleared Traditional

ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM

K052308 · Fisher Diagnostics · Immunology
May 2006
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K052308 is an FDA 510(k) clearance for the ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM, 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 May 10, 2006, 259 days after receiving the submission on August 24, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K052308 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2005
Decision Date May 10, 2006
Days to Decision 259 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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