Cleared Traditional

IQ TT4 ASSAY

K931295 · Becton Dickinson Advanced Diagnostics · Chemistry
Jul 1993
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K931295 is an FDA 510(k) clearance for the IQ TT4 ASSAY, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Becton Dickinson Advanced Diagnostics (Sparks, US). The FDA issued a Cleared decision on July 20, 1993, 127 days after receiving the submission on March 15, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K931295 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1993
Decision Date July 20, 1993
Days to Decision 127 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDX — Radioimmunoassay, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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