COUNTER (BETA, GAMMA) FOR CLINICAL USE MANUFACTURED BY BALLARD MEDICAL PRODUCTS

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COUNTER (BETA, GAMMA) FOR CLINICAL USE

Request for Information Form	Contact Information
Company Name	BALLARD MEDICAL PRODUCTS
Address	12050 LONE PEAK PKWY.
City, State, Zip	DRAPER, UT 84020
Country	US
FDA Owner/Operator Phone	972-281-1200
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	JJJ
FDA Classification Name	COUNTER (BETA, GAMMA) FOR CLINICAL USE
FDA Device Classification Code	General Controls
FDA Regulation Number	862.2320
FDA Common Generic Name	COUNTER (BETA, GAMMA) FOR CLINICAL USE
FDA Proprietary Device Name	COUNTER (BETA, GAMMA) FOR CLINICAL USE
FDA Owner / Operator Number	9001775
FDA Owner / Operator Name	KIMBERLY-CLARK CORP.
FDA Establishment Registration Number	1719891
FDA Registered Establishment Name	BALLARD MEDICAL PRODUCTS
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	12-22-99
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of BALLARD MEDICAL PRODUCTS

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	BECKMAN COULTER, INC. 4300 N. HARBOR BLVD. FULLERTON, CA 92835 US 714-871-4848 / 714-993-5321 8383	LS6000 OR LS COUNTER	LIQUID SCINTILLATION COUNTER
2	BIODEX MEDICAL SYSTEMS, INC. 20 RAMSAY RD. SHIRLEY, NY 11967 US 631-924-9000 / 631-924-9000 2343	MULTIPLE	VARIOUS TYPES OF COUNTERS
3	CAPINTEC, INC. 620 ALPHA DR. PITTSBURGH, PA 15238 US 412-963-1988 / 412-963-1988		VARIOUS TYPES OF GAMMA COUNTERS
4	DAXOR OAK RIDGE OPERATIONS 106 UNION VALLEY RD. OAK RIDGE, TN 37830 US 212-244-0805 / 865-425-0555	DAXOR DGCX1 GAMMA COUNTER	GAMMA COUNTER
5	GAMMASONICS 90 QUEENS ROAD FIVE DOCK NSW 2046, AS 847-299-8450 / 847-299-8450	AUSTRALRAD	VARIOUS TYPES OF COUNTERS
6	INTEGRATED TECHNOLOGIES LTD., WILJ MEDICAL DIVISIO VIKING HOUSE ELLINGHAM WAY ASHFORD, KENT, TN23 6NF UK 01-233-638383x219 / 757-224-0177	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
7	LABORATORY TECHNOLOGIES, INC. 43 W 900 ROUTE 64 MAPLE PARK, IL 60151 US / 630-365-1000	GENESYS	GAMMA COUNTER
8	LUDLUM MEASUREMENTS, INC. 501 OAK ST. SWEETWATER, TX 79556 US 325-235-5494 / 325-235-5494
9	MGM INSTRUMENTS 925 SHERMAN AVE. HAMDEN, CT 06514 US 203-248-4008 / 203-248-4008	ISOCOMP I	VARIOUS MODELS OF ISOCOMP I
10	REFLEX INDUSTRIES, INC. 9530 PATHWAY ST., SUITE 105 SANTEE, CA 92071 US / 619-562-1821	ISO-CALIBRATOR	I-125 OR CO-57 REFERENCE SOURCES
11	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	GENESYS GAMMA COUNTER SAMPLE TUBE CARRIER	SAMPLE TUBE CARRIER
12	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 3400 MIDDLEBURY ST. ELKHART, IN 46514 US 914-524-2955 / 914-524-2955	THYRIMETER DIRECT RATIO READING GAMMA COUNTER	DIRECT RADIO READING GAMMA COUNTER
13	TITERTEK INSTRUMENTS, INC. 330 WYNN DR. HUNTSVILLE, AL 35805 US 256-859-8600 622 / 256-859-8600 622	APEX SERIES, PLUS SERIES	AUTOMATED LIQUID SCINTILLATION COUNTER