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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 K071648
Device Name EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS
Applicant
Canterbury Scientific , Ltd.
14 Pope St.
Riccarton
Christchurch,  NZ 8001
Applicant Contact MAURICE OWEN
Correspondent
Canterbury Scientific , Ltd.
14 Pope St.
Riccarton
Christchurch,  NZ 8001
Correspondent Contact MAURICE OWEN
Regulation Number862.1660
Classification Product Code
JJX  
Date Received06/18/2007
Decision Date 08/22/2007
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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