Name: Predicase
Price: 199 USD

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.
Product code	NBW
Device class	Class II
Decision date	Oct 10, 2025
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.