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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K063855
Device Name LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047
Applicant
Liberty Healthcare Group, Inc.
940 Crossroads Blvd.
Seguin,  TX  78155
Applicant Contact JOHN C GORMLEY
Correspondent
Liberty Healthcare Group, Inc.
940 Crossroads Blvd.
Seguin,  TX  78155
Correspondent Contact JOHN C GORMLEY
Regulation Number862.1660
Classification Product Code
JJX  
Date Received12/28/2006
Decision Date 02/01/2007
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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