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U.S. Department of Health and Human Services

Product Classification
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Device kit, quality control for blood banking reagents
Regulation Description Quality control kit for blood banking reagents.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeKSF
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 864.9650
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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