FDA 510(k) Application Details - K043071

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K043071
Device Name	Enzyme Immunoassay, Phencyclidine
Applicant	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM BT29 4QY GB Other 510(k) Applications for this Company
Contact	P. ARMSTRONG 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	11/08/2004
Decision Date	01/27/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review