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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blood, occult, colorimetric, in urine
510(k) Number K082811
Device Name URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS
Applicant
URIT MEDICAL ELECTRONIC CO., LTD.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Applicant Contact MARIA GRIFFIN
Correspondent
URIT MEDICAL ELECTRONIC CO., LTD.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Correspondent Contact MARIA GRIFFIN
Regulation Number864.6550
Classification Product Code
JIO  
Subsequent Product Codes
CDM   CEN   JIL   JIN   JIR  
JJB   JMA   JMT   KQO   KSL   LJX  
Date Received09/24/2008
Decision Date 09/11/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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