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U.S. Department of Health and Human Services

Product Classification

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Device clozapine test system
Definition A clozapine test system is intended for the in vitro quantitative measurement of clozapine in human specimens.
Physical State In vitro diagnostic device
Technical Method Immunoassay
Target Area Human specimens
Regulation Medical Specialty Clinical Chemistry
Review Panel Toxicology
Product CodeQKT
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3245
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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