HEMATOLOGY CALIBRATOR MANUFACTURED BY R & D SYSTEMS, INC.

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Request for Information Form	Contact Information
Company Name	R & D SYSTEMS, INC.
Address	614 MCKINLEY PL., N.E.
City, State, Zip	MINNEAPOLIS, MN 55413
Country	US
FDA Owner/Operator Phone	612-379-2956
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	KSA
FDA Classification Name	CALIBRATOR FOR RED-CELL AND WHITE-CELL COUNTING
FDA Device Classification Code	Standards
FDA Regulation Number	864.8185
FDA Common Generic Name	CALIBRATOR FOR RED CELL AND WHITE CELL COUNTING
FDA Proprietary Device Name	HEMATOLOGY CALIBRATOR
FDA Owner / Operator Number	2182501
FDA Owner / Operator Name	R & D SYSTEMS, INC.
FDA Establishment Registration Number	2182501
FDA Registered Establishment Name	R & D SYSTEMS, INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	07-10-92
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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4	HORIBA ABX, INC. 34 BUNSEN DR. IRVINE, CA 92618 US 33-467-141516 / 949-453-0500 208	HAEM-CAL	MULTI-PARAMETER WHOLE BLOOD CALIBRATOR