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U.S. Department of Health and Human Services

Product Classification

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Device enzyme linked immunosorbent assay, thrombus precursor protein
Review Panel Hematology
Product CodeMRF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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