Cleared Traditional

AXSYM(TM) TOTAL T4

K934384 · Abbott Laboratories · Chemistry
Jun 1994
Decision
293d
Days
Class 2
Risk

About This 510(k) Submission

K934384 is an FDA 510(k) clearance for the AXSYM(TM) TOTAL T4, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 21, 1994, 293 days after receiving the submission on September 1, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K934384 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 1993
Decision Date June 21, 1994
Days to Decision 293 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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