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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Indirect Immunofluorescent Solid Phase
510(k) Number K172244
Device Name EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
Applicant
Euroimmun Us, Inc.
1 Bloomfield Ave.
Mountain Lakes,  NJ  07046
Applicant Contact Daniel Castellanos
Correspondent
Euroimmun Us, Inc.
1 Bloomfield Ave.
Mountain Lakes,  NJ  07046
Correspondent Contact Daniel Castellanos
Regulation Number866.5100
Classification Product Code
KTL  
Subsequent Product Code
PIV  
Date Received07/26/2017
Decision Date 04/20/2018
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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