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FDA 510(k)

ADVIA Centaur CA 125II

K-Number: K200199 · 2020-04-06

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2020-04-06
Product CodeLTK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur CA 125II 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 2020-04-06 under 510(k) number K200199. The device is classified under product code LTK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur CA 125II?

ADVIA Centaur CA 125II is a medical device that received FDA 510(k) clearance on 2020-04-06. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K200199.

When did ADVIA Centaur CA 125II receive FDA 510(k) clearance?

ADVIA Centaur CA 125II received FDA 510(k) clearance on 2020-04-06, under 510(k) number K200199.

Who is the listed applicant for ADVIA Centaur CA 125II?

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 CA 125II?

The FDA product code for ADVIA Centaur CA 125II is LTK.

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Related Devices (Code: LTK)

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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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