SALA MANUFACTURED BY ORTHO-CLINICAL DIAGNOSTICS, INC.

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Request for Information Form	Contact Information
Company Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
Address	ROUTE 202
City, State, Zip	RARITAN, NJ 08869
Country	US
FDA Owner/Operator Phone	908-218-8177
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GJN
FDA Classification Name	FLUID, DILUTING, RED-CELL
FDA Device Classification Code	General Controls
FDA Regulation Number	864.8200
FDA Common Generic Name	SALINE DILUENT FOR RED CELLS
FDA Proprietary Device Name	SALA
FDA Owner / Operator Number	2250051
FDA Owner / Operator Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
FDA Establishment Registration Number	2250051
FDA Registered Establishment Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	10-28-92
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	E K IND., INC. 1403 HERKLMER ST. JOLIET, IL 60432 US 815-723-4000 / 815-723-4000	HAYEM DILUTING FLUID	HAYEM DILUTING FLUID
2	MEDICAL CHEMICAL CORP. 19430 VAN NESS AVE TORRANCE, CA 90501 US 310-787-6800 / 310-787-6800 235		GOWER'S SOLUTION
3	POCHEMCO, INC. 724 MAIN HOLYOKE, MA 01040 US 413-536-2900 / 413-536-2900	GOWER'S REAGENT	GOWER'S REAGENT
4	R. J. HARVEY INSTRUMENT CORP. 123 PATTERSON ST. HILLSDALE, NJ 07642 US 201-664-1380 / 201-664-1380		HEMATOLOGY-RED BLOOD CELL 3152
5	RICCA CHEMICAL COMPANY LLC 1841 BROAD ST. POCOMOKE CITY, MD 21851 US 817-461-5601 / 888-467-4222 305	HAYEM DILUTING FLUID	HAYEM DILUTING FLUID
6	RICCA CHEMICAL COMPANY LLC 1490 LAMMERS PIKE BATESVILLE, IN 47006 US 817-461-5601 / 817-461-5601	HAYEM DILUTING FLUID	HAYEM DILUTING FLUID
7	RICCA CHEMICAL COMPANY LLC 448 WEST FORK DR. ARLINGTON, TX 76012 US 817-461-5601 / 817-461-5601	HAYEM DILUTING FLUID	HAYEM DILUTING FLUID
8	ROMARK 80 EARHART DR., UNIT 3 WILLIAMSVILLE, NY 14221 US 201-664-1380 / 201-664-1380		HEMATOLOGY-RED BOOD CELL 3152