FDA 510(k) Application Details - K032279

Device Classification Name	Amikacin Serum Assay   More FDA Info for this Device
510(K) Number	K032279
Device Name	Amikacin Serum Assay
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	KERWIN KAUFMAN Other 510(k) Applications for this Contact
Regulation Number	862.3035   More FDA Info for this Regulation Number
Classification Product Code	KLP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2003
Decision Date	10/10/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review