Cleared Traditional

CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

K013568 · Bayer Corp. · Immunology
Dec 2001
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K013568 is an FDA 510(k) clearance for the CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM, a System, Test, Carcinoembryonic Antigen (Class II — Special Controls, product code DHX), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on December 21, 2001, 56 days after receiving the submission on October 26, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K013568 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2001
Decision Date December 21, 2001
Days to Decision 56 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHX — System, Test, Carcinoembryonic Antigen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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