Cleared Traditional

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

K250085 · ACON Laboratories, Inc. · Chemistry
Oct 2025
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K250085 is an FDA 510(k) clearance for the On Call? Sure GK Blood Glucose & Ketone Monitoring System; On Call? Sure Sync GK Blood Glucose & Ketone Monitoring System, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by ACON Laboratories, Inc. (Diego, US). The FDA issued a Cleared decision on October 10, 2025, 270 days after receiving the submission on January 13, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K250085 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2025
Decision Date October 10, 2025
Days to Decision 270 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code NBW — System, Test, Blood Glucose, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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