ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY +1 more— 510(k) K133156

Name: FDA 510(k) clearance K133156
Creator: U.S. Food and Drug Administration
Published: 2014-07-24

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K133156 for ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY +1 more, Substantially Equivalent on 2014-07-24. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.

Clearance details

Device name as filed: ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA
Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code MRG
Device class: Class 2
Regulation: 21 CFR 862.1825
Advisory panel: Clinical Chemistry
Date received: 2013-10-17
Decision date: 2014-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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