Regulatory filing

K233655 (us_fda)

FDA 510(k) K233655 for Abbott Lingo Glucose Biosensor (May 2024). OTC continuous glucose monitor.

fda 510k · cleared · decided 2024-05-01

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing number: K233655
Filing date: 2024-05-01
Decision date: 2024-05-01
Verification posture: verified

Applicant

Covered models (1)

Lingo

Sources (1)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233655

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Identity

37d4e93c-f2f0-4001-bf05-8dfd106f9d21