Device Listing 1270833195

Listing Summary#

Listing key
1270833195
Premarket submission
K250085
Device
On CallĀ® Sure GK Blood Glucose & Ketone Monitoring System; On CallĀ® Sure Sync GK Blood Glucose & Ketone Monitoring System
Applicant
ACON Laboratories, Inc.
Product code
NBW
Decision date
2025-10-10