Cleared Traditional

TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System

K173345 · Taidoc Technology Corporation · Chemistry
May 2018
Decision
192d
Days
Class 1
Risk

About This 510(k) Submission

K173345 is an FDA 510(k) clearance for the TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System, a Nitroprusside, Ketones (urinary, Non-quant.) (Class I — General Controls, product code JIN), submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on May 4, 2018, 192 days after receiving the submission on October 24, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1435.

Submission Details

510(k) Number K173345 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2017
Decision Date May 04, 2018
Days to Decision 192 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIN — Nitroprusside, Ketones (urinary, Non-quant.)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1435

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