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510(k) K233655

Device
Lingo Glucose System
Applicant
Abbott
510(k) number
K233655
Product code
SAF
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-29
Date received
2023-11-14
Regulation
862.1355
Classification name
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Juni Sarkar
Address
1360 S. Loop Rd. Alameda CA US 94502 94502

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SAF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261359Stelo Glucose Biosensor SystemDexcom, Inc.2026-05-21
K250106Signos Glucose Monitoring SystemSignos, Inc.2025-03-21
K234070Stelo Glucose Biosensor SystemDexcom, Inc.2024-03-05