FDA 510(k) Application Details - K231804

Device Classification Name	Media, Culture, Ex Vivo, Tissue And Cell   More FDA Info for this Device
510(K) Number	K231804
Device Name	Media, Culture, Ex Vivo, Tissue And Cell
Applicant	Fujifilm Irvine Scientific 1830 E. Warner Ave Santa Ana, CA 92705 US Other 510(k) Applications for this Company
Contact	Amanda Cinquin Other 510(k) Applications for this Contact
Regulation Number	876.5885   More FDA Info for this Regulation Number
Classification Product Code	NDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2023
Decision Date	11/09/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review