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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 K073030
Device Name AG-605 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Andon Health Co, Ltd.
Ya An Rd. Nankai District
Tiajin,  CN 300190
Applicant Contact MS. MONA
Correspondent
Andon Health Co, Ltd.
Ya An Rd. Nankai District
Tiajin,  CN 300190
Correspondent Contact MS. MONA
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received10/26/2007
Decision Date 07/21/2008
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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