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	KRX
FDA Classification Name	CALIBRATOR FOR CELL INDICES
FDA Device Classification Code	Standards
FDA Regulation Number	864.8150
FDA Common Generic Name	CALIBRATOR FOR CELL INDICES
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	BECKMAN COULTER, INC. 740 WEST 83RD ST. HIALEAH, FL 33014 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	CALIBRATOR FOR CELL INDICES
2	BOULE MEDICAL AB VASTBERGA ALLE' 32 P.O. BOX 42056 STOCKHOLM, SE-126 13 SW 468-744-7700 / 468-744-7700	CALIBRATOR FOR USE ON AUTOMATED HEMATOLOGY ANALYZERS	CALIBRATOR FOR USE ON AUTOMATED HEMATOLOGY ANALYZERS
3	CLINICAL DIAGNOSTIC SOLUTIONS, INC. 1800 N.W. 65TH AVE. PLANTATION, FL 33313 US 468-744-7700 / 954-791-1773	CALIBRATOR FOR USE ON AUTOMATED HEMATOLOGY ANALYZERS	CALIBRATOR FOR USE ON AUTOMATED HEMATOLOGY ANALYZERS
4	HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER, 34184 FR 33-467-141516 / 33-467-14 73 92	MULTIPLE	VARIOUS
5	HORIBA ABX, INC. 34 BUNSEN DR. IRVINE, CA 92618 US 33-467-141516 / 949-453-0500 208	HAEM-CAL	CALIBRATOR FOR CELL INDICES