URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS

Blood, Occult, Colorimetric, In Urine

URIT MEDICAL ELECTRONIC CO., LTD.

The following data is part of a premarket notification filed by Urit Medical Electronic Co., Ltd. with the FDA for Uritest 10g & 11g Urine Reagent Strips And Uritest-50 And Uritest-500b Urine Analyzers.

Pre-market Notification Details

Device IDK082811
510k NumberK082811
Device Name:URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS
ClassificationBlood, Occult, Colorimetric, In Urine
Applicant URIT MEDICAL ELECTRONIC CO., LTD. 55 Northern Blvd. Suite 200 Great Neck,  NY  11021
ContactMaria Griffin
CorrespondentMaria Griffin
URIT MEDICAL ELECTRONIC CO., LTD. 55 Northern Blvd. Suite 200 Great Neck,  NY  11021
Product CodeJIO  
Subsequent Product CodeCDM
Subsequent Product CodeCEN
Subsequent Product CodeJIL
Subsequent Product CodeJIN
Subsequent Product CodeJIR
Subsequent Product CodeJJB
Subsequent Product CodeJMA
Subsequent Product CodeJMT
Subsequent Product CodeKQO
Subsequent Product CodeKSL
Subsequent Product CodeLJX
CFR Regulation Number864.6550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-24
Decision Date2009-09-11
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.