Cleared Traditional

TC MATRIX CLINICAL CHEMISTRY ANALYZER

K073370 · Teco Diagnostics · Chemistry
May 2008
Decision
160d
Days
Class 1
Risk

About This 510(k) Submission

K073370 is an FDA 510(k) clearance for the TC MATRIX CLINICAL CHEMISTRY ANALYZER, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on May 8, 2008, 160 days after receiving the submission on November 30, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K073370 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2007
Decision Date May 08, 2008
Days to Decision 160 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2160

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