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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
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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