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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 K080273
Device Name AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION
Applicant
Fujirebio Diagnostics Texas, Inc.
940 Crossroads Blvd.
Seguin,  TX  78155
Applicant Contact JOHN GORMLEY
Correspondent
Fujirebio Diagnostics Texas, Inc.
940 Crossroads Blvd.
Seguin,  TX  78155
Correspondent Contact JOHN GORMLEY
Regulation Number862.1660
Classification Product Code
JJX  
Date Received02/01/2008
Decision Date 08/08/2008
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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