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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
510(k) Number K182703
Device Name EntericBio Dx Assay
Applicant
Serosep , Ltd.
Annacotty Business Park
Annacotty,  IE V94 FF83
Applicant Contact David Clancy
Correspondent
MDC Associates, LLC
180 Cabot St.
Beverly,  MA  01915
Correspondent Contact Fran White
Regulation Number866.3990
Classification Product Code
PCH  
Date Received09/27/2018
Decision Date 06/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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