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U.S. Department of Health and Human Services

Product Classification

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Device lead, protoporphyrin zinc method, fluorometric
Regulation Description Lead test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeDNX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3550
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