FDA 510(k) Application Details - K133642

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K133642
Device Name	Enzyme Immunoassay, Opiates
Applicant	BIOPHOR DIAGNOSTICS, INC. 1201 DOUGLAS AVE REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	Nathaniel G Butlin 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	11/27/2013
Decision Date	01/24/2014
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