Cleared Special

KetoSens BT Blood B-Ketone Monitoring System

K201551 · I-Sens, Inc. · Chemistry
Sep 2020
Decision
92d
Days
Class 1
Risk

About This 510(k) Submission

K201551 is an FDA 510(k) clearance for the KetoSens BT 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 September 9, 2020, 92 days after receiving the submission on June 9, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1435.

Submission Details

510(k) Number K201551 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2020
Decision Date September 09, 2020
Days to Decision 92 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

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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