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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 K060510
Device Name DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
Applicant
Drew Scientific , Ltd.
Sowerby Woods Business Park
Park Rd.
Barrow In Furness Cumbria,  GB LA14 4QR
Applicant Contact DIANE HILL
Correspondent
Drew Scientific , Ltd.
Sowerby Woods Business Park
Park Rd.
Barrow In Furness Cumbria,  GB LA14 4QR
Correspondent Contact DIANE HILL
Regulation Number862.1660
Classification Product Code
JJX  
Date Received02/27/2006
Decision Date 06/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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