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U.S. Department of Health and Human Services

Product Classification

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Device high pressure liquid chromatography, tricyclic antidepressant drugs
Regulation Description Tricyclic antidepressant drugs test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeLFI
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3910
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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