FDA 510(k) Application Details - K240670

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K240670
Device Name	Enzyme Immunoassay, Amphetamine
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	862.3100   More FDA Info for this Regulation Number
Classification Product Code	DKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2024
Decision Date	10/30/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review