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U.S. Department of Health and Human Services

Product Classification

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Device enzyme immunoassay, cocaine and cocaine metabolites
Regulation Description Cocaine and cocaine metabolite test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeDIO
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
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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