Cleared Traditional

IMMULITE (TM) TOTAL T3

K905214 · Cirrus Diagnostics, Inc. · Chemistry
Feb 1991
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K905214 is an FDA 510(k) clearance for the IMMULITE (TM) TOTAL T3, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Cirrus Diagnostics, Inc. (Chester, US). The FDA issued a Cleared decision on February 1, 1991, 73 days after receiving the submission on November 20, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number K905214 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 1990
Decision Date February 01, 1991
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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