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U.S. Department of Health and Human Services

Product Classification

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Device fibrinogen and split products, rhodamine, antigen, antiserum, control
Regulation Description Fibrinogen determination system.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeDAR
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible