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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 K180196
Device Name On Call Express Mobile Blood Glucose Monitoring System
Applicant
ACON Laboratories, Inc.
10125 Mesa Rim Rd.
San Diego,  CA  92126
Applicant Contact Qiyi Xie
Correspondent
ACON Laboratories, Inc.
10125 Mesa Rim Rd.
San Diego,  CA  92126
Correspondent Contact Qiyi Xie
Regulation Number862.1345
Classification Product Code
NBW  
Date Received01/24/2018
Decision Date 03/07/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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