K-number	K232672
Device name	EasyScreen Gastrointestinal Parasite Detection Kit
Applicant	Genetic Signatures Limited
Product code	PCH
Device class	Class II
Decision date	May 29, 2024
Decision	Substantially Equivalent
Regulation	866.3990

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Source

View the full FDA submission: accessdata.fda.gov

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EasyScreen Gastrointestinal Parasite Detection Kit

Everything you need for a 510(k) submission. Nothing you don't.