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U.S. Department of Health and Human Services

Product Classification

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Device system, fibrinogen determination
Regulation Description Fibrinogen determination system.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeKQJ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.7340
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons
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