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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK042080/A004
Test Name Home Diagnostics, Good Neighbor Pharmacy TRUEread Blood Glucose Monitoring System   
Manufacturer NameHome Diagnostics, Inc.
Consumer Information Phone Number(800)803-6025
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date07/03/2007
Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K042080
Device Name TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
Applicant
Home Diagnostics, Inc.
2400 NW 55th Ct.
Fort Lauderdale,  FL  33309
Applicant Contact KAREN DEVINCENT
Correspondent
Home Diagnostics, Inc.
2400 NW 55th Ct.
Fort Lauderdale,  FL  33309
Correspondent Contact KAREN DEVINCENT
Regulation Number862.1660
Classification Product Code
JJX  
Subsequent Product Code
NBW  
Date Received08/03/2004
Decision Date 08/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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