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U.S. Department of Health and Human Services

Product Classification

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Device colorimetry, cholinesterase
Regulation Description Cholinesterase test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeDIH
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
Third Party Review
Accredited Persons

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