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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Tumor Marker, Monitoring, Bladder
510(k) Number K964151
Device Name BARD AND BTA TEST
Applicant
Bard Diagnostic Sciences,Inc.
12277 134th Ct., NE, #100
Redmond,  WA  98052
Applicant Contact GLEN P FREIBERG
Correspondent
Bard Diagnostic Sciences,Inc.
12277 134th Ct., NE, #100
Redmond,  WA  98052
Correspondent Contact GLEN P FREIBERG
Regulation Number866.6010
Classification Product Code
MMW  
Date Received10/01/1996
Decision Date 04/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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