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U.S. Department of Health and Human Services

Product Classification

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Device u.v. spectrometry, carbamazepine
Regulation Description Neuroleptic drugs radioreceptor assay test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeLDB
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3645
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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