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U.S. Department of Health and Human Services

Product Classification

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Device gas chromatography, methadone
Regulation Description Methadone test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeDMB
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3620
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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