TEC-CONTROL KIT MANUFACTURED BY BIODEX MEDICAL SYSTEMS, INC.

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Request for Information Form	Contact Information
Company Name	BIODEX MEDICAL SYSTEMS, INC.
Address	20 RAMSAY RD.
City, State, Zip	SHIRLEY, NY 11967
Country	US
FDA Owner/Operator Phone	631-924-9000
FDA Medical Specialty Code	TX - Clinical Toxicology
FDA Product Code	KZS
FDA Classification Name	CHROMATOGRAPHY (THIN LAYER), CLINICAL USE
FDA Device Classification Code	General Controls
FDA Regulation Number	862.2270
FDA Common Generic Name	THIN LAYER CHROMATOGRAPHY SYSTEM
FDA Proprietary Device Name	TEC-CONTROL KIT
FDA Owner / Operator Number	2431314
FDA Owner / Operator Name	BIODEX MEDICAL SYSTEMS, INC.
FDA Establishment Registration Number	2431314
FDA Registered Establishment Name	BIODEX MEDICAL SYSTEMS, INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	03-24-04
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 companyies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	GELMAN SCIENCES INC., A WHOLLY OWNED SUBSIDIARY OF 600 SOUTH WAGNER RD. ANN ARBOR, MI 48103 US 734-665-0651 / 734-665-0651 6134	ITLC-SG & ITLC-SA	THIN LAYER CHROMTOGRAPHY