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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: DxH 500 Hematology Analyzer (B40601); DxH 520 Hematology Analyzer (B40602); DxH 560 Hematology Analyzer (B40603)
Classification Name: COUNTER, DIFFERENTIAL CELL
Product Code: GKZ
Device Class: 2
Regulation Number: 864.5220
Medical Specialty: Hematology
Registered Establishment Name: BECKMAN COULTER, INC.
Registered Establishment Number: 1061932
Premarket Submission Number: K181475
Owner/Operator: BECKMAN COULTER, INC.
Owner/Operator Number: 2050012
Establishment Operations: Specification Developer
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