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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
510(k) Number K173568
Device Name NeoBase 2 Non-derivatized MSMS Kit
Applicant
Wallac Oy, Subsidiary of Perkinelmer, Inc.
940 Winter St.
Waltham,  MA  02451
Applicant Contact Brian Carney
Correspondent
Wallac Oy, Subsidiary of Perkinelmer, Inc.
940 Winter St.
Waltham,  MA  02451
Correspondent Contact Anne Marie Whalen
Regulation Number862.1055
Classification Product Code
NQL  
Date Received11/20/2017
Decision Date 09/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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