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U.S. Department of Health and Human Services

Product Classification

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Device fibrin split products
Regulation Description Fibrinogen/fibrin degradation products assay.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGHH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.7320
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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