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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 K141827
Device Name EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
Applicant
EUROIMMUN U.S., Inc.
1100 the american road
morris plains,  NJ  07950
Applicant Contact michael a locke
Correspondent
EUROIMMUN U.S., Inc.
1100 the american road
morris plains,  NJ  07950
Correspodent Contact michael a locke
Regulation Number866.5100
Classification Product Code
DHN  
Subsequent Product Code
PIV  
Date Received07/07/2014
Decision Date 04/17/2015
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
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