IQ200 System, IChemVELOCITY Automated Urine Chemistry System

Counter, Urine Particle

Beckman Coulter, Inc.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Iq200 System, Ichemvelocity Automated Urine Chemistry System.

Pre-market Notification Details

Device IDK210127
510k NumberK210127
Device Name:IQ200 System, IChemVELOCITY Automated Urine Chemistry System
ClassificationCounter, Urine Particle
Applicant Beckman Coulter, Inc. 11800 SW 147th Ave Miami,  FL  33196
ContactMarisa Pugliese
CorrespondentMarisa Pugliese
Beckman Coulter, Inc. 11800 SW 147th Ave Miami,  FL  33196
Product CodeLKM  
Subsequent Product CodeGKL
Subsequent Product CodeJIL
Subsequent Product CodeKQO
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-19
Decision Date2021-07-02

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.