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U.S. Department of Health and Human Services

Product Classification

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Device diabetes take home kit
Definition Diabetes take home kit.
Physical State n/a
Technical Method n/a
Target Area n/a
Review Panel General Hospital
Product CodeOSS
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible