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FDA 510(k)

ADVIA Centaur Cortisol (COR)

K-Number: K192788 · 2019-11-25

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2019-11-25
Product CodeJFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Cortisol (COR) 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 2019-11-25 under 510(k) number K192788. The device is classified under product code JFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur Cortisol (COR)?

ADVIA Centaur Cortisol (COR) is a medical device that received FDA 510(k) clearance on 2019-11-25. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K192788.

When did ADVIA Centaur Cortisol (COR) receive FDA 510(k) clearance?

ADVIA Centaur Cortisol (COR) received FDA 510(k) clearance on 2019-11-25, under 510(k) number K192788.

Who is the listed applicant for ADVIA Centaur Cortisol (COR)?

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 Cortisol (COR)?

The FDA product code for ADVIA Centaur Cortisol (COR) is JFT.

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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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