Cleared Traditional

ADVIA Centaur Vitamin D Total (VitD)

K200509 · Siemens Healthcare Diagnostics, Inc. · Chemistry
May 2020
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K200509 is an FDA 510(k) clearance for the ADVIA Centaur Vitamin D Total (VitD), a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on May 29, 2020, 88 days after receiving the submission on March 2, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.

Submission Details

510(k) Number K200509 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2020
Decision Date May 29, 2020
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MRG — System, Test, Vitamin D
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1825

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