ACON URINALYSIS REAGENT STRIPS MANUFACTURED BY ACON LABORATORIES, INC.

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ACON URINALYSIS REAGENT STRIPS

Request for Information Form	Contact Information
Company Name	ACON LABORATORIES, INC.
Address	4108 SORRENTO VALLEY BLVD.
City, State, Zip	SAN DIEGO, CA 92121
Country	US
FDA Owner/Operator Phone	858-535-2030
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	JIO
FDA Classification Name	BLOOD, OCCULT, COLORIMETRIC, IN URINE
FDA Device Classification Code	Standards
FDA Regulation Number	864.6550
FDA Common Generic Name	URINALYSIS REAGENT STRIPS
FDA Proprietary Device Name	ACON URINALYSIS REAGENT STRIPS
FDA Owner / Operator Number	9063887
FDA Owner / Operator Name	ACON LABORATORIES, INC.
FDA Establishment Registration Number	2531491
FDA Registered Establishment Name	ACON LABORATORIES, INC.
FDA Operation Code(s)	ME - Contract Manufacturer MM - Manufacturer
FDA Listing Date	10-04-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ACON LABORATORIES, INC.

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	ARJ MEDICAL, INC. 209 STATE STREET OLDSMAR, FL 34677 US 813-855-1557 / 813-855-1557	URITEST 10 URINALYSIS REAGENT STRIPS	URINALYSIS REAGENT STRIPS
3	ARKRAY FACTORY USA, INC. 5182 WEST 76TH ST. MINNEAPOLIS, MN 55439 US 81-75-6628964 / 952-646-3168	DIASCREEN REAGENT STRIPS FOR URINALYSIS	URINE TEST STRIPS
4	BAYER HEALTHCARE LLC 555 WHITE PLAINS RD. 5TH FLOOR TARRYTOWN, NY 10591 US 914-524-2955 / 574-262-6372	BILILABSTIX	TEST FOR PH, PROTEIN, GLUCOSE, KETONE, BILIRUBIN & BLOOD IN URINE
5	BAYER HEALTHCARE, LLC 430 SOUTH BEIGER ST. MISHAWAKA, IN 46544 US 914-524-2955 / 574-256-3430	BILILABSTIX	TEST FOR PH, PROTEIN, GLUCOSE, KETONE, BILIRUBIN & BLOOD IN URINE
6	BTNX, INC. 570 HOOD ROAD, UNIT 23 MARKHAM, L3R 4G7 CA 905-944-9565 / 303-234-9412	BIOTECHNOSTIX	OCCULT BLOOD TEST
7	DFI CO., LTD. 542-1 DAMAN-RI, JINRYE-MYUN GIMHAE-CITY, GYUNG-NAM, KS 82-55-3461882 / 909-980-9933	CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS	OCCULT BLOOT TEST
8	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
9	HEALTH CHECK PRODUCTS, INC. 6681 MAGNOLIA AVE., SUITE J RIVERSIDE, CA 92506 US 951-788-2400 / 951-325-7195	HEALTH CHECK COLORECTAL TEST	VISUAL COLOR TEST FOR BLOOD IN STOOL
10	IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 331 SOUTH 104TH ST. LOUISVILLE, CO 80027 US 781-674-3900 / 303-530-6612	URINE TEST STRIP	URINE TEST STRIP
11	KIMBALL ELECTRONICS (WALES) LIMITED WESTERN AVENUE BRIDGEND INDUSTRIAL ESTATE BRIDGEND, WALES, CF31 3TY UK 812-634-4172 / 44-163-5566448	BILILABSTIX	PH,PROTEIN,GLUCOSE,KETONE,BILIRUBIN & BLOOD IN URINE
12	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 3400 MIDDLEBURY ST. ELKHART, IN 46514 US 914-524-2955 / 914-524-2955	BILILABSTIX	TEST FOR PH, PROTEIN, GLUCOSE, KETONE, BILIRUBIN & BLOOD IN URINE
13	STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772	URI-QUICK 10SG	URINARY BLOOD