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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 K121534
Device Name CONE-TROL HEMOGLOBIN A1C CONTROL SET
Applicant
Cone Bioproducts
1012 N Austin St.
Seguin,  TX  78155
Applicant Contact GAIL SCHIEVELBEIN
Correspondent
Cone Bioproducts
1012 N Austin St.
Seguin,  TX  78155
Correspondent Contact GAIL SCHIEVELBEIN
Regulation Number862.1660
Classification Product Code
JJX  
Date Received05/24/2012
Decision Date 06/20/2012
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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