FDA 510(k) Application Details - K240041

Device Classification Name	More FDA Info for this Device
510(K) Number	K240041
Device Name	IVD CAPSULE PSP; abioSCOPE
Applicant	Abionic SA Route de la Corniche 5 Epalinges 1066 CH Other 510(k) Applications for this Company
Contact	Iwan MΣrki Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2024
Decision Date	09/25/2024
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