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FDA 510(k)

Access Free T4

K-Number: K240273 · 2024-03-06

ApplicantBeckman Coulter, Inc.
Decision Date2024-03-06
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access Free T4 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 2024-03-06 under 510(k) number K240273. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access Free T4?

Access Free T4 is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K240273.

When did Access Free T4 receive FDA 510(k) clearance?

Access Free T4 received FDA 510(k) clearance on 2024-03-06, under 510(k) number K240273.

Who is the listed applicant for Access Free T4?

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 Free T4?

The FDA product code for Access Free T4 is CEC.

Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: CEC)

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.

K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, Inc.

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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