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FDA 510(k)

Elecsys Folate III

K-Number: K233060 · 2024-06-17

ApplicantRoche Diagnostics
Decision Date2024-06-17
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys Folate III is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2024-06-17 under 510(k) number K233060. 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 Elecsys Folate III?

Elecsys Folate III is a medical device that received FDA 510(k) clearance on 2024-06-17. The listed applicant is Roche Diagnostics. The 510(k) number is K233060.

When did Elecsys Folate III receive FDA 510(k) clearance?

Elecsys Folate III received FDA 510(k) clearance on 2024-06-17, under 510(k) number K233060.

Who is the listed applicant for Elecsys Folate III?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elecsys Folate III?

The FDA product code for Elecsys Folate III 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.

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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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