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FDA 510(k)

ADVIA Centaur® Anti-Müllerian Hormone (AMH)

K-Number: K221801 · 2023-06-02

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2023-06-02
Product CodePQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur® Anti-Müllerian Hormone (AMH) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-06-02 under approval number K221801. The device is classified under product code PQO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur® Anti-Müllerian Hormone (AMH)?

ADVIA Centaur® Anti-Müllerian Hormone (AMH) is a medical device that received FDA 510(k) clearance on 2023-06-02. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K221801.

When was ADVIA Centaur® Anti-Müllerian Hormone (AMH) approved by the FDA?

ADVIA Centaur® Anti-Müllerian Hormone (AMH) received FDA 510(k) clearance on 2023-06-02, under approval number K221801.

What company makes ADVIA Centaur® Anti-Müllerian Hormone (AMH)?

ADVIA Centaur® Anti-Müllerian Hormone (AMH) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for ADVIA Centaur® Anti-Müllerian Hormone (AMH)?

The FDA product code for ADVIA Centaur® Anti-Müllerian Hormone (AMH) is PQO.

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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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