Diabetes Take Home Kit

Device Code: 2863

Product Code(s): OSS

Definition: Diabetes Take Home Kit

Device Classification Information

Device Type ID2863
Device NameDiabetes Take Home Kit
Physical StateN/a
Technical MethodN/a
Target AreaN/a
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission TypeEnforcement Discretion
FDA Device ClassificationClass Not Classified Medical Device
Product CodeOSS
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2863
DeviceDiabetes Take Home Kit
Product CodeOSS
TPLC Last Update: 2019-04-02 20:20:14

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