Cleared Traditional

ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS

K012777 · Bayer Corp. · Immunology
Oct 2001
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K012777 is an FDA 510(k) clearance for the ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on October 22, 2001, 63 days after receiving the submission on August 20, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K012777 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 2001
Decision Date October 22, 2001
Days to Decision 63 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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