FDA 510(k) Application Details - K012978

Device Classification Name	Enzyme Immunoassay, Gentamicin   More FDA Info for this Device
510(K) Number	K012978
Device Name	Enzyme Immunoassay, Gentamicin
Applicant	RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN BT29 4QY IE Other 510(k) Applications for this Company
Contact	PAULINE ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	862.3450   More FDA Info for this Regulation Number
Classification Product Code	LCD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2001
Decision Date	09/18/2001
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