Cleared Traditional

ABBOTT ARCHITECT FREE T3

K983439 · Abbott Laboratories · Chemistry
Nov 1998
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K983439 is an FDA 510(k) clearance for the ABBOTT ARCHITECT FREE T3, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 20, 1998, 52 days after receiving the submission on September 29, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number K983439 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 1998
Decision Date November 20, 1998
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDP — Radioimmunoassay, Total Triiodothyronine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1710

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