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510(k) K172252

EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern by Euroimmun Us, Inc. — Product Code KTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2018
Date Received
July 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Indirect Immunofluorescent Solid Phase
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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