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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 K974845
Device Name BTA STAT TEST PRESCRIPTION HOME USE
Applicant
Bard Diagnostic Sciences,Inc.
12277 134th Ct., NE, #100
Redmond,  WA  98052
Applicant Contact Glen Paul Freiberg
Correspondent
Bard Diagnostic Sciences,Inc.
12277 134th Ct., NE, #100
Redmond,  WA  98052
Correspondent Contact Glen Paul Freiberg
Regulation Number866.6010
Classification Product Code
MMW  
Date Received12/18/1997
Decision Date 12/08/1998
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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