FDA 510(k) Application Details - K232103

Device Classification Name	More FDA Info for this Device
510(K) Number	K232103
Device Name	Terragene« Chemdye« Multivariable Chemical Indicator (CD40), Terragene« Chemdye« Chemical Process Indicator (CD42), Terragene« Cintape« Chemical Process Indicator Tape (CT40)
Applicant	Terragene SA Ruta Nacional No. 9, Km 280, Parque Industrial Micropi Alvear 2130 AR Other 510(k) Applications for this Company
Contact	Hernando Carrizo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2023
Decision Date	04/05/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review