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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antinuclear antibody, indirect immunofluorescent, antigen, control
510(K) Number K120889
Model 51.100.US
Device Name AESKUSLIDES ANA HEP-2
Applicant
AESKU DIAGNOSTICS
87 pedricktown-woodstown rd.
pedricktown,  NJ  08067
Contact helene paxton
Regulation Number866.5100
Classification Product Code
DHN  
Date Received03/23/2012
Decision Date 10/15/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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