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U.S. Department of Health and Human Services

Product Classification

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Device test, thrombin time
Regulation Description Thrombin time test.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGJA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.7875
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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