Cleared Traditional

ADVIA Centaur CA 125II

K200199 · Siemens Healthcare Diagnostics, Inc. · Immunology
Apr 2020
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K200199 is an FDA 510(k) clearance for the ADVIA Centaur CA 125II, a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II — Special Controls, product code LTK), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on April 6, 2020, 70 days after receiving the submission on January 27, 2020. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K200199 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2020
Decision Date April 06, 2020
Days to Decision 70 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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