Cleared Traditional

ADVIA Centaur? Total hCG assay

K200210 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Jul 2021
Decision
532d
Days
Class 2
Risk

About This 510(k) Submission

K200210 is an FDA 510(k) clearance for the ADVIA Centaur? Total hCG assay, a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on July 13, 2021, 532 days after receiving the submission on January 28, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K200210 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2020
Decision Date July 13, 2021
Days to Decision 532 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DHA — System, Test, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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