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U.S. Department of Health and Human Services

Product Classification

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Device liquid chromatography, diphenylhydantoin
Regulation Description Diphenylhydantoin test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeDOZ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3350
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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