Cleared Traditional

Carbon Dioxide Reagent Set

K170200 · Teco Diagnostics, Inc. · Chemistry
Jun 2017
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K170200 is an FDA 510(k) clearance for the Carbon Dioxide Reagent Set, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Teco Diagnostics, Inc. (Anaheim, US). The FDA issued a Cleared decision on June 1, 2017, 129 days after receiving the submission on January 23, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K170200 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2017
Decision Date June 01, 2017
Days to Decision 129 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHS — Enzymatic, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

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