AFP DIFFERENTIAL KIT, AFP-L3% TEST, AFP STANDARD MANUFACTURED BY WAKO PURE CHEM., DIAG. RESEARCH LABS

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Request for Information Form	Contact Information
Company Name	WAKO PURE CHEM., DIAG. RESEARCH LABS
Address	6-1 TAKADA-CHO
City, State, Zip	AMAGASAKI, HYOGO-KEN,
Country	JA
FDA Owner/Operator Phone	816-620-33741
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	NSF
FDA Classification Name	TEST, ALPHA FETOPROTEIN L3 SUBFRACTION (AFP-L3%), FOR HEPATOCELLULAR CARCINOMA RISK ASSESSMENT
FDA Device Classification Code	Standards
FDA Regulation Number	866.6030
FDA Common Generic Name	AFP TEST KIT & AFP STANDARD
FDA Proprietary Device Name	AFP DIFFERENTIAL KIT, AFP-L3% TEST, AFP STANDARD
FDA Owner / Operator Number	8030234
FDA Owner / Operator Name	WAKO PURE CHEMICAL INDUSTRIES, LTD.
FDA Establishment Registration Number	3003419906
FDA Registered Establishment Name	WAKO PURE CHEM., DIAG. RESEARCH LABS
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	07-22-05
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	WAKO CHEMICALS USA, INC. 1600 BELLWOOD ROAD RICHMOND, VA 23237 US 816-620-33741 / 650-210-9153 109	AFP DIFFERENTIAL KIT, AFP-L3% TEST, AFP STANDARD	AFP TEST KIT & AFP STANDARD
2	WAKO PURE CHEMICAL INDUSTRIES, LTD. 2613-2 OAZA OGOHARA KOMONO-CHO MIE, 510-1222 JA 816-620-33741 / 650-210-9153 109	LBA AFP-L3, AFP-L3 CALIBRATOR SET AFP-L3 CONTROL SET	AFP TEST KIT & AFP STANDARD