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U.S. Department of Health and Human Services

Product Classification

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Device activated whole blood clotting time
Regulation Description Activated whole blood clotting time tests.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJBP
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.7140
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 Standard
Third Party Review
Accredited Persons
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