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U.S. Department of Health and Human Services

Product Classification

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Device fibrinogen and fibrin split products, antigen, antiserum, control
Regulation Description Fibrinogen/fibrin degradation products assay.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeDAP
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.7320
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review
Accredited Persons
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