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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
Submission Type 510(k)
Regulation Number 862.2050
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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