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U.S. Department of Health and Human Services

Product Classification

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Device test, cannabinoid, over the counter
Regulation Description Cannabinoid test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeNFW
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3870
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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