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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK090057
Test Name Acon Laboratories, On-Call Plus Blood Glucose Monitoring System  
Manufacturer NameAcon Laboratories Co.
Consumer Information Phone Number(800)838-9502
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date04/30/2009
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K090057
Device Name ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Acon Laboratories Co.
4108 Sorrento Valley Blvd.
San Diego,  CA  92121
Applicant Contact RICHARD LENART
Correspondent
Acon Laboratories Co.
4108 Sorrento Valley Blvd.
San Diego,  CA  92121
Correspondent Contact RICHARD LENART
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received01/08/2009
Decision Date 04/08/2009
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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