Cleared Traditional

TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM

K053020 · Bayer Healthcare, LLC · Chemistry
Dec 2005
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K053020 is an FDA 510(k) clearance for the TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Bayer Healthcare, LLC (New York, US). The FDA issued a Cleared decision on December 30, 2005, 65 days after receiving the submission on October 26, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K053020 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2005
Decision Date December 30, 2005
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MMI — Immunoassay Method, Troponin Subunit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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