Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2020-08-30 under 510(k) 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. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K201405.

When did LabPro Data Management System receive FDA 510(k) clearance?

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

Who is the listed applicant for LabPro Data Management System?

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 LabPro Data Management System?

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

Other records listing Beckman Coulter, Inc. as applicant

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.

K252169Access BNP IIK254059Access anti-HBc IgMK253687Access anti-HBc TotalK251995Access anti-HAV IgMK250588Access Rubella IgGPMA P980041KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

View all 84 devices →

Related Devices (Code: LON)

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.

K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUXK251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)Becton, Dickinson and CompanyK250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and CompanyK234012VITEK COMPACT PRObioMerieux, 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.

↑