FDA 510(k) Application Details - K011771

Device Classification Name	Enzyme Immunoassay, Theophylline   More FDA Info for this Device
510(K) Number	K011771
Device Name	Enzyme Immunoassay, Theophylline
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	862.3880   More FDA Info for this Regulation Number
Classification Product Code	KLS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2001
Decision Date	01/17/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review