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U.S. Department of Health and Human Services

Product Classification

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Device dna-probe, b and t lymphocyte
Regulation Description Automated differential cell counter.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeMAM
Premarket Review Division of Immunology and Hematology Devices (DIHD)
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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