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U.S. Department of Health and Human Services

Product Classification

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Device high pressure liquid chromatography, cocaine and cocaine metabolites
Regulation Description Cocaine and cocaine metabolite test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeLAC
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3250
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests - Draft Guidance for Industry and FDA Staff
Third Party Review
Accredited Persons

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