FDA 510(k) Application Details - DEN190028

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN190028
Device Name	MyCare Psychiatry Clozapine Assay Kit
Applicant	Saladax Biomedical Inc 116 Research Drive Bethlehem, PA 18015 US Other 510(k) Applications for this Company
Contact	Sue Werner Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2019
Decision Date	04/16/2020
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review