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U.S. Department of Health and Human Services

Product Classification

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Device enzyme immunoassay, primidone
Regulation Description Primidone test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeDJD
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3680
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons