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U.S. Department of Health and Human Services

Product Classification

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Device fluorescence polarization immunoassay, carbamazepine
Regulation Description Neuroleptic drugs radioreceptor assay test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeLGI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3645
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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