Cleared Traditional

FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM

K971141 · Dade Chemistry Systems, Inc. · Chemistry

Apr 1997

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K971141 is an FDA 510(k) clearance for the FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Dade Chemistry Systems, Inc. (Newark, US). The FDA issued a Cleared decision on April 28, 1997, 31 days after receiving the submission on March 28, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number	K971141 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 1997
Decision Date	April 28, 1997
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF