Cleared Traditional

BTA STAT TEST PRESCRIPTION HOME USE

K974845 · Bard Diagnostic Sciences,Inc. · Immunology
Dec 1998
Decision
355d
Days
Class 2
Risk

About This 510(k) Submission

K974845 is an FDA 510(k) clearance for the BTA STAT TEST PRESCRIPTION HOME USE, 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 December 8, 1998, 355 days after receiving the submission on December 18, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K974845 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1997
Decision Date December 08, 1998
Days to Decision 355 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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