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U.S. Department of Health and Human Services

Product Classification
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Device radioimmunoassay, phencyclidine
Review Panel Toxicology
Product CodeLCL
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests - Draft Guidance for Industry and FDA Staff
Third Party Review Not Third Party Eligible
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