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U.S. Department of Health and Human Services

Product Classification

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Device antithrombin iii quantitation
Regulation Description Antithrombin III assay.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJBQ
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.7060
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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