FDA 510(k) Application Details - K033884

Device Classification Name	Radioimmunoassay, Amikacin   More FDA Info for this Device
510(K) Number	K033884
Device Name	Radioimmunoassay, Amikacin
Applicant	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM BT29 4QY GB Other 510(k) Applications for this Company
Contact	PAULINE ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	862.3035   More FDA Info for this Regulation Number
Classification Product Code	KLQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2003
Decision Date	06/09/2004
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