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U.S. Department of Health and Human Services

Product Classification

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Device cholinesterase test paper
Regulation Description Cholinesterase test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeDIG
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Enforcement Discretion
Regulation Number 862.3240
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons