MULTIPLE MANUFACTURED BY HORIBA ABX

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Request for Information Form	Contact Information
Company Name	HORIBA ABX
Address	PARC EUROMEDECINE RUE DU CADUCEE, BP 7290
City, State, Zip	MONTPELLIER,
Country	FR
FDA Owner/Operator Phone	33-467-141516
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	VARIOUS
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	9036328
FDA Owner / Operator Name	HORIBA ABX
FDA Establishment Registration Number	3000148879
FDA Registered Establishment Name	HORIBA ABX
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-29-00
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, 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