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U.S. Department of Health and Human Services

Product Classification

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Device automated radioimmunoassay systems, for clinical use
Regulation Description General purpose laboratory equipment labeled or promoted for a specific medical use.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeLCI
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.2050
Device Class 1
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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