Cleared Traditional

DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300

K020687 · Axis-Shield Diagnostics, Ltd. · Immunology
May 2002
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K020687 is an FDA 510(k) clearance for the DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on May 2, 2002, 59 days after receiving the submission on March 4, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K020687 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2002
Decision Date May 02, 2002
Days to Decision 59 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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