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FDA 510(k)

LabPro Data Management System

K-Number: K201405 · 2020-08-30

ApplicantBeckman Coulter, Inc.
Decision Date2020-08-30
Product CodeLON
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LabPro Data Management System is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2020-08-30 under approval number K201405. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LabPro Data Management System?

LabPro Data Management System is a medical device that received FDA 510(k) clearance on 2020-08-30. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K201405.

When was LabPro Data Management System approved by the FDA?

LabPro Data Management System received FDA 510(k) clearance on 2020-08-30, under approval number K201405.

What company makes LabPro Data Management System?

LabPro Data Management System is manufactured by Beckman Coulter, Inc..

What is the FDA product code for LabPro Data Management System?

The FDA product code for LabPro Data Management System is LON.

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40246726 [Brief Discussion on the General Requirements of Quality Management System of Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 40061911 Engineering a Quality Management System for Academic Research: Navigating Challenges to Comply with the New Medical Device Regulations in Europe. Medical devices (Auckland, N.Z.) (2025)

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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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