Last synced on 14 November 2025 at 11:06 pm

On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System

Page Type
Cleared 510(K)
510(k) Number
K250085
510(k) Type
Traditional
Applicant
ACON Laboratories, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/10/2025
Days to Decision
270 days
Submission Type
Statement

On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System

Page Type
Cleared 510(K)
510(k) Number
K250085
510(k) Type
Traditional
Applicant
ACON Laboratories, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/10/2025
Days to Decision
270 days
Submission Type
Statement