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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 K250085
Device Name On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System
Applicant
ACON Laboratories, Inc.
9440 Carroll Park Dr.
San Diego,  CA  92121
Applicant Contact Catherine Shi
Correspondent
MCRA, an IQVIA Company
803 7th St. NW
Washington,  DC  20001
Correspondent Contact James Mullally
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JIN  
Date Received01/13/2025
Decision Date 10/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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