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U.S. Department of Health and Human Services

Product Classification

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Device device, automated cell-locating
Regulation Description Automated cell-locating device.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJOY
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.5260
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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