FDA 510(k) Application Details - K232672

Device Classification Name	More FDA Info for this Device
510(K) Number	K232672
Device Name	EasyScreen Gastrointestinal Parasite Detection Kit
Applicant	Genetic Signatures Limited 7 Eliza St Newtown 2042 AU Other 510(k) Applications for this Company
Contact	Neralie Coulston Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2023
Decision Date	05/29/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review