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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name antibodies, gliadin
510(k) Number K113863
Model 701168, 701173, 701166, 701171
Device Name QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS
Original Applicant
INOVA DIAGNOSTICS, INC.
9900 old grove rd.
san diego,  CA  92131 1638
Original Contact gabriella lakos
Regulation Number866.5750
Classification Product Code
MST  
Subsequent Product Codes
JIX   JJX  
Date Received12/30/2011
Decision Date 09/20/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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