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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK103037
Test Name SCI International Inc. New Choice Urinary Tract Infection (UTI) Test Strips  
Manufacturer NameIND DIAGNOSTIC, INC.
Consumer Information Phone Number1(800)351-0177
Test TypeUrine qualitative dipstick leukocytes
Effective Date09/25/2012
Device Classification Name test, nitrite, urinary, non-quantitative, over the counter
510(k) Number K103037
Device Name IND URINARY TRACT INFECTION (UTI) TEST STRIPS
Applicant
IND DIAGNOSTIC, INC.
1629 FOSTERS WAY
DELTA, B.C.,  CA V3M 6S7
Applicant Contact KAI LOU
Correspondent
IND DIAGNOSTIC, INC.
1629 FOSTERS WAY
DELTA, B.C.,  CA V3M 6S7
Correspondent Contact KAI LOU
Regulation Number862.1510
Classification Product Code
NGJ  
Subsequent Product Code
LJX  
Date Received10/14/2010
Decision Date 04/17/2012
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 No
Combination Product No
Recalls CDRH Recalls
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