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U.S. Department of Health and Human Services

Product Classification

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Device system, automated platelet aggregation
Regulation Description Automated platelet aggregation system.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJOZ
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.5700
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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