Cleared Traditional

ADVIA Centaur CEA Assay

K200215 · Siemens Healthcare Disgnostics, Inc. · Immunology

Apr 2020

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K200215 is an FDA 510(k) clearance for the ADVIA Centaur CEA Assay, a System, Test, Carcinoembryonic Antigen (Class II — Special Controls, product code DHX), submitted by Siemens Healthcare Disgnostics, Inc. (New York, US). The FDA issued a Cleared decision on April 13, 2020, 76 days after receiving the submission on January 28, 2020. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K200215 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 2020
Decision Date	April 13, 2020
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF