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	JCN
FDA Classification Name	CONTROL, CELL COUNTER, NORMAL AND ABNORMAL
FDA Device Classification Code	Standards
FDA Regulation Number	864.8625
FDA Common Generic Name	CELL COUNTER CONTROL MATERIALS
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

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ABBOTT LABORATORIES 5440 PATRICK HENRY DR. SANTA CLARA, CA 95054 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS CELL COUNTER CONTROLS
2	BECKMAN COULTER, INC. 740 WEST 83RD ST. HIALEAH, FL 33014 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	HEMATOLOGY QUALITY CONTROL MATERIAL