IQ 200 URINE ANALYZER BODY FLUIDS MODULE

Counter, Cell, Automated (particle Counter)

IRIS INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Iris International, Inc. with the FDA for Iq 200 Urine Analyzer Body Fluids Module.

Pre-market Notification Details

Device IDK050235
510k NumberK050235
Device Name:IQ 200 URINE ANALYZER BODY FLUIDS MODULE
ClassificationCounter, Cell, Automated (particle Counter)
Applicant IRIS INTERNATIONAL, INC. 9172 ETON AVE. Chatsworth,  CA  91311
ContactHarvey L Kasdan
CorrespondentHarvey L Kasdan
IRIS INTERNATIONAL, INC. 9172 ETON AVE. Chatsworth,  CA  91311
Product CodeGKL  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-01
Decision Date2005-03-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10837461002475 K050235 000

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