FDA 510(k) Application Details - K011393

Device Classification Name	Enzyme Immunoassay, Diphenylhydantoin   More FDA Info for this Device
510(K) Number	K011393
Device Name	Enzyme Immunoassay, Diphenylhydantoin
Applicant	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, CO. ANTRIM BT29 4QY IE Other 510(k) Applications for this Company
Contact	P. ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	862.3350   More FDA Info for this Regulation Number
Classification Product Code	DIP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2001
Decision Date	12/04/2001
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