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U.S. Department of Health and Human Services

Product Classification
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Device test, residual, wbc in leukoreduced blood
Regulation Description Hematology quality control mixture.
Definition CBER
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeMZG
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 864.8625
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 Not Third Party Eligible
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