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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Real Time Nucleic Acid Amplification System
510(k) Number K123955
Device Name QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
Applicant
Life Technologies Corporation
5791 Van Allen Way
Carlsbad,  CA  92008
Applicant Contact DEANNA VELLA
Correspondent
Life Technologies Corporation
5791 Van Allen Way
Carlsbad,  CA  92008
Correspondent Contact DEANNA VELLA
Regulation Number862.2570
Classification Product Code
OOI  
Date Received12/21/2012
Decision Date 03/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
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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