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U.S. Department of Health and Human Services

Product Classification

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Device plasma, fibrinogen control
Regulation Description Fibrinogen determination system.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGIL
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.7340
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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