FDA 510(k) Application Details - DEN220042

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220042
Device Name	Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
Applicant	Terragene SA Ruta Nacional No. 9, Km 280, Parque Industrial Micropi Alvear 2130 AR Other 510(k) Applications for this Company
Contact	Catalano Maximiliano Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2022
Decision Date	07/12/2024
Decision	DENG -
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review