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FDA 510(k)

ADVIA Centaur Vitamin D Total (VitD)

K-Number: K200509 · 2020-05-29

Decision Date2020-05-29
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Vitamin D Total (VitD) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-05-29 under 510(k) 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. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K200509.

When did ADVIA Centaur Vitamin D Total (VitD) receive FDA 510(k) clearance?

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

Who is the listed applicant for ADVIA Centaur Vitamin D Total (VitD)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Siemens Healthcare Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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