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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 K101371
Device Name ON CALL PLUS DIABETES MONITORING SOFTWARE
Applicant
ACON Laboratories, Inc.
10125 Mesa Rim Rd.
San Diego,  CA  92121
Applicant Contact RICHARD LENART
Correspondent
ACON Laboratories, Inc.
10125 Mesa Rim Rd.
San Diego,  CA  92121
Correspondent Contact RICHARD LENART
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received05/17/2010
Decision Date 01/07/2011
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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