IRISPECIFIC GRAVITY DEVICE 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	GU - Gastroenterology/Urology
FDA Product Code	EXS
FDA Classification Name	URINOMETER, ELECTRICAL
FDA Device Classification Code	Standards
FDA Regulation Number	876.1800
FDA Common Generic Name	SPECIFIC GRAVITY METER
FDA Proprietary Device Name	IRISPECIFIC GRAVITY DEVICE
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	12-09-92
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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3	PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. ANDOVER, MA 01810 US 425-487-7000 / 978-659-4252	MULTIPLE	URINOMETER, ELECTRICAL
4	PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 BOEBLINGEN, D 71034 GM 425-487-7000 / 978-659-4252	MULTIPLE	URINOMETER, ELECTRICAL