BARD BTA TRAK TEST

System, Test, Tumor Marker, Monitoring, Bladder

BARD DIAGNOSTIC SCIENCES,INC.

The following data is part of a premarket notification filed by Bard Diagnostic Sciences,inc. with the FDA for Bard Bta Trak Test.

Pre-market Notification Details

Device IDK971402
510k NumberK971402
Device Name:BARD BTA TRAK TEST
ClassificationSystem, Test, Tumor Marker, Monitoring, Bladder
Applicant BARD DIAGNOSTIC SCIENCES,INC. 12277 134TH COURT, N.E. #100 Redmond,  WA  98052
ContactGlen P Freiberg
CorrespondentGlen P Freiberg
BARD DIAGNOSTIC SCIENCES,INC. 12277 134TH COURT, N.E. #100 Redmond,  WA  98052
Product CodeMMW  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-15
Decision Date1998-04-15
Summary:summary

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