NEONATAL CHEMISTRY SYSTEM (NCS), GALT TEST MANUFACTURED BY WALLAC OY

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Request for Information Form	Contact Information
Company Name	WALLAC OY
Address	MUSTIONKATU 6
City, State, Zip	TURKU,
Country	FI
FDA Owner/Operator Phone	781-663-6900
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	KQP
FDA Classification Name	FLUORESCENT PROC. (QUAL.), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE
FDA Device Classification Code	Standards
FDA Regulation Number	862.1315
FDA Common Generic Name	G-1P OR GALT TEST
FDA Proprietary Device Name	NEONATAL CHEMISTRY SYSTEM (NCS), GALT TEST
FDA Owner / Operator Number	9912035
FDA Owner / Operator Name	PERKINELMER, INC.
FDA Establishment Registration Number	8043909
FDA Registered Establishment Name	WALLAC OY
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-10-04
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	ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. CLACKAMAS, OR 97015 US 503-657-3010 / 503-657-3010	SPOTCHECK LLRIDYLTRANSFERASE 50 HOUR REAGENT KIT	FOR DETERMINATION OF GALACTOSE-1-PHOSPHATE URIDYL TRASNFERASE ACTIVITY IN W.BLOD
2	BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. HERCULES, CA 94547 US 510-724-7000 / 510-741-6263	FLUORESCENT PROC. (QUAL.), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE	CODA GALT ASSAY