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FDA 510(k)

Access Folate Assay

K-Number: K223590 · 2023-08-23

ApplicantBeckman Coulter, Inc.
Decision Date2023-08-23
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access Folate Assay 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 2023-08-23 under 510(k) number K223590. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access Folate Assay?

Access Folate Assay is a medical device that received FDA 510(k) clearance on 2023-08-23. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K223590.

When did Access Folate Assay receive FDA 510(k) clearance?

Access Folate Assay received FDA 510(k) clearance on 2023-08-23, under 510(k) number K223590.

Who is the listed applicant for Access Folate Assay?

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 Folate Assay?

The FDA product code for Access Folate Assay is CGN.

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Related Devices (Code: CGN)

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.

K233060Elecsys Folate IIIRoche DiagnosticsK192586LIAISON® FolateDiaSorin, Inc.K172201Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc.K161646Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetDiazyme Laboratories

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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