IRIS 939UDX URINE PATHOLOGY SYSTEM MANUFACTURED BY IRIS DIAGNOSTICS

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Request for Information Form	Contact Information
Company Name	IRIS DIAGNOSTICS
Address	9172 ETON AVE.
City, State, Zip	CHATSWORTH, CA 91311
Country	US
FDA Owner/Operator Phone	818-709-1244 7129
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 URINALYSIS SYSTEM
FDA Proprietary Device Name	IRIS 939UDX URINE PATHOLOGY SYSTEM
FDA Owner / Operator Number	2023446
FDA Owner / Operator Name	IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I
FDA Establishment Registration Number	2023446
FDA Registered Establishment Name	IRIS DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	10-09-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	PORTABLE MEDICAL LABORATORIES, INC. 544 SOUTH NARDO AVE. SOLANA BEACH, CA 92075 US 858-755-7385 / 858-755-7385		URINOSCOPY FUNNEL
2	SYSMEX CORPORATION 4-4-4 TAKATSUKADAI NISHI-KU KOBE, 651-2271 JA 817-826-50500 / 847-996-4512	SYSMEX UF-SERIES	AUTOMATED URINE ANALYZER