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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dna Genetic Analyzer
510(k) Number K191030
Device Name Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer
Applicant
Life Technologies Corporation
5781 Van Allen Way
Carlsbad,  CA  92008
Applicant Contact Darcie Baynes
Correspondent
Life Technologies Corporation
5781 Van Allen Way
Carlsbad,  CA  92008
Correspondent Contact Darcie Baynes
Regulation Number862.2570
Classification Product Code
PCA  
Date Received04/18/2019
Decision Date 02/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
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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