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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
Device Name AESKUSLIDES ANA HEP-2
Applicant
Aesku Diagnostics
87 Pedricktown-Woodstown Rd.
Pedricktown,  NJ  08067
Applicant Contact HELENE PAXTON
Correspondent
Aesku Diagnostics
87 Pedricktown-Woodstown Rd.
Pedricktown,  NJ  08067
Correspondent Contact HELENE PAXTON
Regulation Number866.5100
Classification Product Code
DHN  
Date Received03/23/2012
Decision Date 10/15/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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