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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 K093916
Device Name NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U
Applicant
Perkinelmer, Inc.
8275 Carloway Rd.
Indianapolis,  IN  46236
Applicant Contact KAY TAYLOR
Correspondent
Perkinelmer, Inc.
8275 Carloway Rd.
Indianapolis,  IN  46236
Correspondent Contact KAY TAYLOR
Regulation Number862.1055
Classification Product Code
NQL  
Date Received12/22/2009
Decision Date 08/23/2010
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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