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U.S. Department of Health and Human Services

Product Classification

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Device fluorescence polarization immunoassay, theophylline
Regulation Description Theophylline test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeLGS
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3880
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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