CALIBRATOR FOR USE ON AUTOMATED HEMATOLOGY ANALYZERS MANUFACTURED BY BOULE MEDICAL AB

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Request for Information Form	Contact Information
Company Name	BOULE MEDICAL AB
Address	VASTBERGA ALLE' 32 P.O. BOX 42056
City, State, Zip	STOCKHOLM,
Country	SW
FDA Owner/Operator Phone	468-744-7700
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 USE ON AUTOMATED HEMATOLOGY ANALYZERS
FDA Proprietary Device Name	CALIBRATOR FOR USE ON AUTOMATED HEMATOLOGY ANALYZERS
FDA Owner / Operator Number	9034165
FDA Owner / Operator Name	BOULE MEDICAL AB
FDA Establishment Registration Number	3004008703
FDA Registered Establishment Name	BOULE MEDICAL AB
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	09-23-04
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	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
3	HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER, 34184 FR 33-467-141516 / 33-467-14 73 92	MULTIPLE	VARIOUS
4	HORIBA ABX, INC. 34 BUNSEN DR. IRVINE, CA 92618 US 33-467-141516 / 949-453-0500 208	HAEM-CAL	CALIBRATOR FOR CELL INDICES
5	R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. MINNEAPOLIS, MN 55413 US 612-379-2956 / 800-328-2400 4413	HEMATOLOGY CALIBRATOR	CALIBRATOR FOR CELL INDICES