Cleared Traditional

DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

K073604 · Dade Behring, Inc. · Chemistry
Mar 2008
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K073604 is an FDA 510(k) clearance for the DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on March 13, 2008, 83 days after receiving the submission on December 21, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number K073604 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2007
Decision Date March 13, 2008
Days to Decision 83 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEC — Radioimmunoassay, Free Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1695

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