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U.S. Department of Health and Human Services

Product Classification

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Device counter, cell, automated (particle counter)
Regulation Description Automated cell counter.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGKL
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.5200
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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