Cleared Traditional

TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM

K060120 · Teco Diagnostics · Chemistry
Mar 2006
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K060120 is an FDA 510(k) clearance for the TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on March 27, 2006, 69 days after receiving the submission on January 17, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K060120 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2006
Decision Date March 27, 2006
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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