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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameJant Pharmacal Accutest UA 50 Urine Chemistry Analyzer  
Document NumberK063390
Parent Document NumberK063390
Analyte NameUrine qualitative dipstick urobilinogen
Analyte SpecialtyUrinalysis
ComplexityMODERATE
Effective Date05/02/2007
Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K063390
Device Name URINE CHEMISTRY ANALYZER UR-50
Applicant
Ind Diagnostic, Inc.
P.O. Box 162
Altamonte Springs,  FL  32716
Applicant Contact BRIAN LEMAY
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact RAYLENE BALARD
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JIN   JIO   JIR  
JJB   JMT   JRE   KQO   LJX  
Date Received11/09/2006
Decision Date 03/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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