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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 Division of Immunology and Hematology Devices (DIHD)
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
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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