Cleared Traditional

BARD BTA TRAK TEST

K971402 · Bard Diagnostic Sciences,Inc. · Immunology
Apr 1998
Decision
365d
Days
Class 2
Risk

About This 510(k) Submission

K971402 is an FDA 510(k) clearance for the BARD BTA TRAK TEST, a System, Test, Tumor Marker, Monitoring, Bladder (Class II — Special Controls, product code MMW), submitted by Bard Diagnostic Sciences,Inc. (Redmond, US). The FDA issued a Cleared decision on April 15, 1998, 365 days after receiving the submission on April 15, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K971402 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1997
Decision Date April 15, 1998
Days to Decision 365 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MMW — System, Test, Tumor Marker, Monitoring, Bladder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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