FDA 510(k) Application Details - DEN170010

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170010
Device Name	LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
Applicant	Lin-Zhi International, Inc. 2945 Oakmead Village Court Santa Clara, CA 95051 US Other 510(k) Applications for this Company
Contact	Chris Wang 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	02/21/2017
Decision Date	04/20/2018
Decision	DENG -
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review