FDA 510(k) Application Details - K231007

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K231007
Device Name	Enzyme Immunoassay, Opiates
Applicant	Microgenics Corporation 46500 Kato Road Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Amrit Takhar Other 510(k) Applications for this Contact
Regulation Number	862.3650   More FDA Info for this Regulation Number
Classification Product Code	DJG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2023
Decision Date	09/27/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review