FDA 510(k) Application Details - K991505

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K991505
Device Name	Enzyme Immunoassay, Phencyclidine
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	862.3100   More FDA Info for this Regulation Number
Classification Product Code	LCM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/1999
Decision Date	08/05/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review