DIAZYME LITHIUM ENZYMATIC ASSAY KIT MANUFACTURED BY DIAZYME LABORATORIES

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Request for Information Form	Contact Information
Company Name	DIAZYME LABORATORIES
Address	12889 GREGG COURT
City, State, Zip	POWAY, CA 92064
Country	US
FDA Owner/Operator Phone	858-455-4761
FDA Medical Specialty Code	TX - Clinical Toxicology
FDA Product Code	JII
FDA Classification Name	ATOMIC ABSORPTION, LITHIUM
FDA Device Classification Code	Standards
FDA Regulation Number	862.3560
FDA Common Generic Name	LITHIUM ENZYMATIC ASSAY
FDA Proprietary Device Name	DIAZYME LITHIUM ENZYMATIC ASSAY KIT
FDA Owner / Operator Number	9057184
FDA Owner / Operator Name	GENERAL ATOMICS
FDA Establishment Registration Number	2032900
FDA Registered Establishment Name	DIAZYME LABORATORIES
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	11-03-04
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 companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	CAROLINA LIQUID CHEMISTRIES CORP. 510 W. CENTRAL AVE. SUITE C BREA, CA 92821 US 800-471-7272 / 800-471-7272	LITH	LITHIUM REAGENT
2	ORTHO-CLINICAL DIAGNOSTICS, INC. 300 WEILAND RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768	MULTIPLE	LITHIUM TEST SYSTEM
3	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413	RANDOX LITHIUM	LITHIUM
4	ROWLEY BIOCHEMICAL INSTITUTE, INC. 10 ELECTRONICS AVE. DANVERS INDUSTRIAL PARK DANVERS, MA 01923 US 978-739-4883 / 978-739-4883	LITHIUM TEST KIT	LITHIUM TEST KIT