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U.S. Department of Health and Human Services

Product Classification
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Device container, empty, for collection & processing of blood & blood components
Regulation Description Empty container for the collection and processing of blood and blood components.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeKSR
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 864.9100
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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