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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameARJ Medical URITEST 10 Reagent Strips for Urinalysis  
Document NumberK052719
Parent Document NumberK052719
Analyte NameUrine qualitative dipstick glucose
Analyte SpecialtyUrinalysis
ComplexityWAIVED
Effective Date12/30/2006
Device Classification Name Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
510(k) Number K052719
Device Name URITEST 10 URINALYSIS REAGENT STRIPS
Applicant
Arj Medical, Inc.
209 State St.
Oldsmar,  FL  34677
Applicant Contact AARON BEHAR
Correspondent
Arj Medical, Inc.
209 State St.
Oldsmar,  FL  34677
Correspondent Contact AARON BEHAR
Regulation Number862.1785
Classification Product Code
CDM  
Subsequent Product Codes
CEN   JIL   JIN   JIO   JIR  
JJB   JMT   JRE   LJX  
Date Received09/29/2005
Decision Date 12/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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