Cleared Traditional

CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM

K020828 · Bayer Corp. · Immunology
Jul 2002
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K020828 is an FDA 510(k) clearance for the CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM, a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II — Special Controls, product code LTK), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on July 24, 2002, 132 days after receiving the submission on March 14, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K020828 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2002
Decision Date July 24, 2002
Days to Decision 132 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LTK — Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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