Cleared Traditional

BARD AND BTA TEST

K964151 · Bard Diagnostic Sciences,Inc. · Immunology
Apr 1997
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K964151 is an FDA 510(k) clearance for the BARD AND BTA 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 16, 1997, 197 days after receiving the submission on October 1, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K964151 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1996
Decision Date April 16, 1997
Days to Decision 197 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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