FDA 510(k) Application Details - K973761

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K973761
Device Name	Enzyme Immunoassay, Opiates
Applicant	MICRODIAGNOSTICS, INC. 28062 FORBES ROAD, SUITE B LAGUNA NIGUEL, CA 92677 US Other 510(k) Applications for this Company
Contact	ROY CHUNG 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	10/02/1997
Decision Date	12/24/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review