Source document or public record

FDA 510(k) K201405 — LabPro Data Management System

FDA 510(k) index record K201405. Device: LabPro Data Management System. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2020-08-30.

OtherU.S. Food and Drug Administration (FDA)2020-08-30

Source

"device_name": "LabPro Data Management System"

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 K201405.

Device name: LabPro Data Management System. Applicant as listed: Beckman Coulter, Inc..

Decision date: 2020-08-30. Decision wording: Substantially Equivalent.

Product code: LON. Regulation: 21 CFR 866.1645. Medical specialty: Microbiology.

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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