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U.S. Department of Health and Human Services

Product Classification

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Device platelet factor 4 radioimmunoassay
Regulation Description Platelet factor 4 radioimmunoassay.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeLCO
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.7695
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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