FDA 510(k)

KET-1 Blood Ketone Monitoring System

K-Number: K182593 · 2018-12-18

Decision Date2018-12-18

Product CodeJIN

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

KET-1 Blood Ketone Monitoring System is a medical device manufactured by Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2018-12-18 under approval number K182593. The device is classified under product code JIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KET-1 Blood Ketone Monitoring System?

KET-1 Blood Ketone Monitoring System is a medical device that received FDA 510(k) clearance on 2018-12-18. It is manufactured by Apex BioTechnology Corp.. The 510(k) number is K182593.

When was KET-1 Blood Ketone Monitoring System approved by the FDA?

KET-1 Blood Ketone Monitoring System received FDA 510(k) clearance on 2018-12-18, under approval number K182593.

What company makes KET-1 Blood Ketone Monitoring System?

KET-1 Blood Ketone Monitoring System is manufactured by Apex BioTechnology Corp..

What is the FDA product code for KET-1 Blood Ketone Monitoring System?

The FDA product code for KET-1 Blood Ketone Monitoring System is JIN.

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Other Devices by Apex BioTechnology Corp.

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System K170267BGM009 Plus Blood Glucose Monitoring System K182992BGM014 Blood Glucose Monitoring System K201880MultiSure GK Link Blood Glucose and Ketone Monitoring System K202885GlucoSure HT Plus Blood Glucose Monitoring System K222234GlucoSure ADVANCE Link Blood Glucose Monitoring System

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Related Devices (Code: JIN)

K170587On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for UrinalysisACON Laboratories, Inc. K173345TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology Corporation K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc. K201551KetoSens BT Blood B-Ketone Monitoring SystemI-Sens, Inc. K192957VivaChek Blood Glucose and B-Ketone Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.