FDA 510(k) Application Details - K130275

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K130275
Device Name	Enzyme Immunoassay, Opiates
Applicant	Tianjin New Bay Bioresearch Co., Ltd. 4455 Murphy Canyon Rd Suite 204 San Diego, CA 92123 US Other 510(k) Applications for this Company
Contact	Roger De Bock 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	02/04/2013
Decision Date	09/26/2013
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