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Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated — Abbott Diabetes Care, Inc. (PMA P160030)

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated — Abbott Diabetes Care, Inc. (PMA P160030) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated; Applicant: Abbott Diabetes Care

Device nameSensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
ApplicantAbbott Diabetes Care, Inc.
Clearance trackPMA
Submission numberP160030
DecisionOK30
Decision date2025-07-11
Date received2025-06-16
Product codePZE
Device class3
Medical specialtyUnknown
Applicant locationCA
SourceopenFDA device

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