Cleared Traditional

KET-1 Blood Ketone Monitoring System

K182593 · Apex BioTechnology Corp. · Chemistry
Dec 2018
Decision
89d
Days
Class 1
Risk

About This 510(k) Submission

K182593 is an FDA 510(k) clearance for the KET-1 Blood Ketone Monitoring System, a Nitroprusside, Ketones (urinary, Non-quant.) (Class I — General Controls, product code JIN), submitted by Apex BioTechnology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on December 18, 2018, 89 days after receiving the submission on September 20, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1435.

Submission Details

510(k) Number K182593 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2018
Decision Date December 18, 2018
Days to Decision 89 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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