Source document or public record

FDA 510(k) K240273 — Access Free T4

FDA 510(k) index record K240273. Device: Access Free T4. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-03-06.

OtherU.S. Food and Drug Administration (FDA)2024-03-06

Source

"device_name": "Access Free T4"

This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-20

Disclaimer

professional use

FDA 510(k) public index record K240273.

Device name: Access Free T4. Applicant as listed: Beckman Coulter, Inc..

Decision date: 2024-03-06. Decision wording: Substantially Equivalent.

Product code: CEC. Regulation: 21 CFR 862.1695. Medical specialty: Clinical Chemistry.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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