Cleared Traditional

TECO ISE REAGENT SET FOR CX SYSTEM

K052724 · Teco Diagnostics · Chemistry
Dec 2005
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K052724 is an FDA 510(k) clearance for the TECO ISE REAGENT SET FOR CX SYSTEM, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on December 14, 2005, 76 days after receiving the submission on September 29, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K052724 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2005
Decision Date December 14, 2005
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JGS — Electrode, Ion Specific, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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