FDA 510(k) Application Details - K971402

Device Classification Name	System, Test, Tumor Marker, Monitoring, Bladder   More FDA Info for this Device
510(K) Number	K971402
Device Name	System, Test, Tumor Marker, Monitoring, Bladder
Applicant	BARD DIAGNOSTIC SCIENCES,INC. 12277 134TH COURT, N.E. #100 REDMOND, WA 98052 US Other 510(k) Applications for this Company
Contact	GLEN P FREIBERG Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	MMW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/1997
Decision Date	04/15/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review