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FDA 510(k)

ADVIA Centaur Vitamin D Total (VitD)

K-Number: K200509 · 2020-05-29

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2020-05-29
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Vitamin D Total (VitD) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-05-29 under approval number K200509. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur Vitamin D Total (VitD)?

ADVIA Centaur Vitamin D Total (VitD) is a medical device that received FDA 510(k) clearance on 2020-05-29. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K200509.

When was ADVIA Centaur Vitamin D Total (VitD) approved by the FDA?

ADVIA Centaur Vitamin D Total (VitD) received FDA 510(k) clearance on 2020-05-29, under approval number K200509.

What company makes ADVIA Centaur Vitamin D Total (VitD)?

ADVIA Centaur Vitamin D Total (VitD) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for ADVIA Centaur Vitamin D Total (VitD)?

The FDA product code for ADVIA Centaur Vitamin D Total (VitD) is MRG.

Related Clinical Trials

NCT07150221 MDR Vivacit-E Elevated Study ENROLLING_BY_INVITATION

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Related Devices (Code: MRG)

K161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetImmunodiagnostic Systems , Ltd. K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 ControlsAbbott Laboratories K153361Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D CalibratorsFujirebio Diagnostics,Inc. K162298LOCI Total Vitamin D Total Assay, LOCI VITD CALSiemens Healthcare Diagnostics K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5Roche Diagnostics K162754FREND Vitamin D Test SystemNanoentek USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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