CDS-LTX CONTROL LATEX PARTICLE SUSPENSION MANUFACTURED BY CLINICAL DIAGNOSTIC SOLUTIONS, INC.

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Request for Information Form	Contact Information
Company Name	CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Address	1800 N.W. 65TH AVE.
City, State, Zip	PLANTATION, FL 33313
Country	US
FDA Owner/Operator Phone	468-744-7700
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	LATRON, LATEX CALIBRATOR
FDA Proprietary Device Name	CDS-LTX CONTROL LATEX PARTICLE SUSPENSION
FDA Owner / Operator Number	9034165
FDA Owner / Operator Name	BOULE MEDICAL AB
FDA Establishment Registration Number	1064130
FDA Registered Establishment Name	CLINICAL DIAGNOSTIC SOLUTIONS, INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	05-03-99
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 HEMATOLOGY CALIBRATORS
2	HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER, 34184 FR 33-467-141516 / 33-467-14 73 92	MINOCAL	MULTI-PARAMETER WHOLE BLOOD CALIBRATOR
3	HORIBA ABX, INC. 34 BUNSEN DR. IRVINE, CA 92618 US 33-467-141516 / 949-453-0500 208	HAEM-CAL	MULTI-PARAMETER WHOLE BLOOD CALIBRATOR
4	R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. MINNEAPOLIS, MN 55413 US 612-379-2956 / 800-328-2400 4413	HEMATOLOGY CALIBRATOR	CALIBRATOR FOR RED CELL AND WHITE CELL COUNTING