NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTORMETRY KIT 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	NQL
FDA Classification Name	SYSTEM, TEST, AMINO ACIDS, FREE CARNITINES AND ACYLCARNITINES TANDEM MASS SPECTROMETRY
FDA Device Classification Code	Standards
FDA Regulation Number	862.1055
FDA Common Generic Name	TANDERM MASS SPECTROMETRY ASSAY FOR DETERMINATION OF AMINO ACIDS & ACYLCARNITINE
FDA Proprietary Device Name	NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTORMETRY KIT
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	11-09-05
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 companyies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	PERKINELMER LAS, INC. 940 WINTER STREET WALTHAM, MA 02451 US 781-663-6900 / 782-663-5818	NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPEC	AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPEC KIT