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U.S. Department of Health and Human Services

Product Classification
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Device counter, urine particle
Regulation Description Automated cell counter.
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodeLKM
Submission Type 510(k)
Regulation Number 864.5200
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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