FDA 510(k) Application Details - K043384

Device Classification Name	Enzymatic Radiochemical Assay, Tobramycin   More FDA Info for this Device
510(K) Number	K043384
Device Name	Enzymatic Radiochemical Assay, Tobramycin
Applicant	Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 US Other 510(k) Applications for this Company
Contact	CAREY A MAYO Other 510(k) Applications for this Contact
Regulation Number	862.3900   More FDA Info for this Regulation Number
Classification Product Code	LDO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2004
Decision Date	02/07/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review