CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS MANUFACTURED BY DFI CO., LTD.

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Request for Information Form	Contact Information
Company Name	DFI CO., LTD.
Address	542-1 DAMAN-RI, JINRYE-MYUN
City, State, Zip	GIMHAE-CITY, GYUNG-NAM,
Country	KS
FDA Owner/Operator Phone	82-55-3461882
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	JMA
FDA Classification Name	ACID, ASCORBIC, 2,4-DINITROPHENYLHYDRAZINE (SPECTROPHOTOMETRIC)
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1095
FDA Common Generic Name	ASCORBIC ACID TEST SYSTEM
FDA Proprietary Device Name	CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS
FDA Owner / Operator Number	9089171
FDA Owner / Operator Name	DFI CO., LTD.
FDA Establishment Registration Number	3005841640
FDA Registered Establishment Name	DFI CO., LTD.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-04-06
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	ACON BIOTECH (HANGZHOU) CO., LTD. 398 TIANMUSHAN RD. GUDANG INDUSTRIAL PARK HANGZHOU, P.R., 310023 CH 86-571-03963569 / 858-875-8000 1828	ACON URINALYSIS REAGENT STRIPS	URINALYSIS REAGENT STRIPS
2	ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. SAN DIEGO, CA 92121 US 858-535-2030 / 858-875-8000 1828	ACON URINALYSIS REAGENT STRIPS	URINALYSIS REAGENT STRIPS
3	BTNX, INC. 570 HOOD ROAD, UNIT 23 MARKHAM, L3R 4G7 CA 905-944-9565 / 303-234-9412	BIOTECHNOSTIX	ASCORBIC ACID TEST SYSTEM
4	CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH HEIMBURGSTRASSE 3 MUNICH, 81243 GM 49-89-189300 / 49-89-18930202	FOLATE, ASCORBIC ACID	ASCORBIC ACID
5	DIRUI INDUSTRIAL CO., LTD. 95 YUNHE ST., NEW & HIGH TECH DEVELOPMENT ZONE CHANGCHUN, 130012 CH 86-431-5100409 / 516-482-9001	DIRUI	MULTIPLE REAGENT STRIPS
6	MACHEREY-NAGEL GMBH & CO., KG. NEUMANN-NEANDER-STRASSE 6-8 DUEREN, 52355 GM 49-242-1969259 / 49-242-1969259	MULTIPLE	VARIOUS
7	PRECISA INTL. CORP. 4890 S.W. 74TH CT. MIAMI, FL 33155 US 305-669-0895 / 305-669-0898	URIDIEZ	URINE TEST
8	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	FOLATE, ASCORBIC ACID	ASCORBIC ACID