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U.S. Department of Health and Human Services

Product Classification

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Device assay, t lymphocyte surface marker
Regulation Description Automated differential cell counter.
Regulation Medical Specialty Hematology
Review Panel Immunology
Product CodeLIZ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.5220
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
Third Party Review
Accredited Persons
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