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 |
|