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FDA 510(k)

Access Cortisol

K-Number: K223038 · 2023-02-08

ApplicantBeckman Coulter, Inc.
Decision Date2023-02-08
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access Cortisol is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2023-02-08 under 510(k) number K223038. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access Cortisol?

Access Cortisol is a medical device that received FDA 510(k) clearance on 2023-02-08. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K223038.

When did Access Cortisol receive FDA 510(k) clearance?

Access Cortisol received FDA 510(k) clearance on 2023-02-08, under 510(k) number K223038.

Who is the listed applicant for Access Cortisol?

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

What is the FDA product code for Access Cortisol?

The FDA product code for Access Cortisol is CGR.

Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: CGR)

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.

K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc.K202136IDS CortisolImmunodiagnostic Systems , Ltd.K203270IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K202826IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd.

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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