FDA 510(k) Application Details - K190397

Device Classification Name	More FDA Info for this Device
510(K) Number	K190397
Device Name	Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
Applicant	Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767 US Other 510(k) Applications for this Company
Contact	Yang Yang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2019
Decision Date	11/15/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review