Cleared Traditional

IQ TUPTAKE ASSAY

K931294 · Becton Dickinson Advanced Diagnostics · Chemistry
Jul 1993
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K931294 is an FDA 510(k) clearance for the IQ TUPTAKE ASSAY, a Radioassay, Triiodothyronine Uptake (Class II — Special Controls, product code KHQ), submitted by Becton Dickinson Advanced Diagnostics (Sparks, US). The FDA issued a Cleared decision on July 22, 1993, 129 days after receiving the submission on March 15, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1715.

Submission Details

510(k) Number K931294 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1993
Decision Date July 22, 1993
Days to Decision 129 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHQ — Radioassay, Triiodothyronine Uptake
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1715

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