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U.S. Department of Health and Human Services

Product Classification
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Device system, hemoglobin, automated
Regulation Description Automated hemoglobin system.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGKR
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 864.5620
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
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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