FDA 510(k) Application Details - K011303

Device Classification Name	Enzyme Immunoassay, Phenobarbital   More FDA Info for this Device
510(K) Number	K011303
Device Name	Enzyme Immunoassay, Phenobarbital
Applicant	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, CO. ANTRIM BT29 4QY IE Other 510(k) Applications for this Company
Contact	PAULINE ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	862.3660   More FDA Info for this Regulation Number
Classification Product Code	DLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2001
Decision Date	07/02/2001
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