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U.S. Department of Health and Human Services

Product Classification

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Device plasma, coagulation control
Regulation Description Multipurpose system for in vitro coagulation studies.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGGN
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.5425
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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