FDA 510(k) Application Details - K240247

Device Classification Name	Media, Culture, Ex Vivo, Tissue And Cell   More FDA Info for this Device
510(K) Number	K240247
Device Name	Media, Culture, Ex Vivo, Tissue And Cell
Applicant	DuoGenic StemCells Corporation No. 18, Ln. 10, Taiping 21st St., Taiping Dist. Taichung City 41161 TW Other 510(k) Applications for this Company
Contact	Hong Lin Su 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	01/30/2024
Decision Date	07/12/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review