Cleared Traditional

OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN

K081615 · Olympus America, Inc. · Immunology
Mar 2009
Decision
282d
Days
Class 2
Risk

About This 510(k) Submission

K081615 is an FDA 510(k) clearance for the OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN, a System, Test, Carcinoembryonic Antigen (Class II — Special Controls, product code DHX), submitted by Olympus America, Inc. (Co. Clare, IE). The FDA issued a Cleared decision on March 18, 2009, 282 days after receiving the submission on June 9, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K081615 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2008
Decision Date March 18, 2009
Days to Decision 282 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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