Cleared Traditional

IMMULITE(TM) T-UPTAKE

K910677 · Cirrus Diagnostics, Inc. · Chemistry
Apr 1991
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K910677 is an FDA 510(k) clearance for the IMMULITE(TM) T-UPTAKE, a Radioimmunoassay, Thyroxine-binding Globulin (Class II — Special Controls, product code CEE), submitted by Cirrus Diagnostics, Inc. (Chester, US). The FDA issued a Cleared decision on April 29, 1991, 73 days after receiving the submission on February 15, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1685.

Submission Details

510(k) Number K910677 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1991
Decision Date April 29, 1991
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CEE — Radioimmunoassay, Thyroxine-binding Globulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1685

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