Cleared Traditional

KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System

K170463 · I-Sens, Inc. · Chemistry
Apr 2018
Decision
422d
Days
Class 1
Risk

About This 510(k) Submission

K170463 is an FDA 510(k) clearance for the KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System, a Nitroprusside, Ketones (urinary, Non-quant.) (Class I — General Controls, product code JIN), submitted by I-Sens, Inc. (Seoul, KR). The FDA issued a Cleared decision on April 13, 2018, 422 days after receiving the submission on February 15, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1435.

Submission Details

510(k) Number K170463 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 2017
Decision Date April 13, 2018
Days to Decision 422 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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