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U.S. Department of Health and Human Services

Product Classification

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Device fluorescence polarization immunoassay for cyclosporine
Regulation Description Cyclosporine test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Toxicology
Product CodeMGU
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1235
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
Guidance Document
Third Party Review
Accredited Persons
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