SYSMEX UF-SERIES MANUFACTURED BY SYSMEX CORPORATION

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Request for Information Form	Contact Information
Company Name	SYSMEX CORPORATION
Address	4-4-4 TAKATSUKADAI NISHI-KU
City, State, Zip	KOBE,
Country	JA
FDA Owner/Operator Phone	817-826-50500
FDA Medical Specialty Code	PA - Pathology
FDA Product Code	LKM
FDA Classification Name	COUNTER, URINE PARTICLE
FDA Device Classification Code	Standards
FDA Regulation Number	864.5200
FDA Common Generic Name	AUTOMATED URINE ANALYZER
FDA Proprietary Device Name	SYSMEX UF-SERIES
FDA Owner / Operator Number	9014170
FDA Owner / Operator Name	SYSMEX CORPORATION
FDA Establishment Registration Number	9613959
FDA Registered Establishment Name	SYSMEX CORPORATION
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	12-03-01
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	IRIS DIAGNOSTICS 9172 ETON AVE. CHATSWORTH, CA 91311 US 818-709-1244 7129 / 818-709-1244 7129	IRIS 939UDX URINE PATHOLOGY SYSTEM	AUTOMATED URINALYSIS SYSTEM
2	PORTABLE MEDICAL LABORATORIES, INC. 544 SOUTH NARDO AVE. SOLANA BEACH, CA 92075 US 858-755-7385 / 858-755-7385		URINOSCOPY FUNNEL