FDA 510(k) Application Details - K964670

Device Classification Name	Fluorescence Polarization Immunoassay, Tobramycin   More FDA Info for this Device
510(K) Number	K964670
Device Name	Fluorescence Polarization Immunoassay, Tobramycin
Applicant	ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 SOMERVILLE, NJ 08876-3771 US Other 510(k) Applications for this Company
Contact	RITA SMITH Other 510(k) Applications for this Contact
Regulation Number	862.3900   More FDA Info for this Regulation Number
Classification Product Code	LFW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/1996
Decision Date	02/04/1997
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