HEMOCULT, HEMOCCULTSENSA MANUFACTURED BY BECKMAN COULTER, INC.

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Request for Information Form	Contact Information
Company Name	BECKMAN COULTER, INC.
Address	606 ELMWOOD AVE.
City, State, Zip	SHARON HILL, PA 19079
Country	US
FDA Owner/Operator Phone	714-871-4848
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GGG
FDA Classification Name	GUAIAC REAGENT
FDA Device Classification Code	Standards
FDA Regulation Number	864.6550
FDA Common Generic Name	FECAL OCCULT BLOOD TEST
FDA Proprietary Device Name	HEMOCULT, HEMOCCULTSENSA
FDA Owner / Operator Number	2050012
FDA Owner / Operator Name	BECKMAN COULTER, INC.
FDA Establishment Registration Number	2518658
FDA Registered Establishment Name	BECKMAN COULTER, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	11-18-92
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	AERSCHER DIAGNOSTICS 353 HIGH ST. CHESTERTOWN, MD 21620 US 410-778-1144 / 410-778-1144	HEMAPROMPT	HEMAPROMPT-FECAL OCCULT BLOOD KIT, HEMASCREEN SEAT COLONCHECK
2	EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED