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U.S. Department of Health and Human Services

Product Classification

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Device procainamide control materials
Regulation Description Clinical toxicology control material.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeLBA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3280
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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