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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K062187
FOIA Releasable 510(k) K062187
Device Name BETACHEK GLUCOSE TEST
Applicant
National Diagnostic Products
22/39 Herbert St.
St. Leonards Nsw 2065
Sydney,  AU
Applicant Contact BRANDON BRANSGROVE
Correspondent
National Diagnostic Products
22/39 Herbert St.
St. Leonards Nsw 2065
Sydney,  AU
Correspondent Contact BRANDON BRANSGROVE
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received08/01/2006
Decision Date 03/24/2009
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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