BTA STAT TEST PRESCRIPTION HOME USE

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 Bta Stat Test Prescription Home Use.

Pre-market Notification Details

Device IDK974845
510k NumberK974845
Device Name:BTA STAT TEST PRESCRIPTION HOME USE
ClassificationSystem, Test, Tumor Marker, Monitoring, Bladder
Applicant BARD DIAGNOSTIC SCIENCES,INC. 12277 134TH COURT, N.E. #100 Redmond,  WA  98052
ContactGlen Paul Freiberg
CorrespondentGlen Paul 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 Received1997-12-18
Decision Date1998-12-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00855574005636 K974845 000
00855574005629 K974845 000
00855574005353 K974845 000
00855574005278 K974845 000
00855574005261 K974845 000
00855574005001 K974845 000
10743816001409 K974845 000
10743816001393 K974845 000

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