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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 K232672
Device Name EasyScreen Gastrointestinal Parasite Detection Kit
Applicant
Genetic Signatures Limited
7 Eliza St
Newtown,  AU 2042
Applicant Contact Neralie Coulston
Correspondent
Genetic Signatures Limited
7 Eliza St
Newtown,  AU 2042
Correspondent Contact Neralie Coulston
Regulation Number866.3990
Classification Product Code
PCH  
Subsequent Product Code
OOI  
Date Received09/01/2023
Decision Date 05/29/2024
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
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