FDA 510(k) Application Details - K991597

Device Classification Name	Fluorescence Polarization Immunoassay, Amibacin   More FDA Info for this Device
510(K) Number	K991597
Device Name	Fluorescence Polarization Immunoassay, Amibacin
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	LISA GERARD Other 510(k) Applications for this Contact
Regulation Number	862.3035   More FDA Info for this Regulation Number
Classification Product Code	LGJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/1999
Decision Date	07/22/1999
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