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U.S. Department of Health and Human Services

Product Classification

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Device antithrombin iii, two stage clotting time assay
Regulation Description Antithrombin III assay.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJPE
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.7060
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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