Class Class II

On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System (K250085)

K250085 2025-10-10 Traditional
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Description

On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System by ACON Laboratories, Inc., an FDA 510(k) cleared clinical chemistry device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250085
Clearance Date2025-10-10
Clearance TypeTraditional
Product CodeNBW
Regulation Number862.1345

Categories

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