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FDA 510(k)

KET-1 Blood Ketone Monitoring System

K-Number: K182593 · 2018-12-18

ApplicantApex BioTechnology Corp.
Decision Date2018-12-18
Product CodeJIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KET-1 Blood Ketone Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2018-12-18 under 510(k) 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. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K182593.

When did KET-1 Blood Ketone Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for KET-1 Blood Ketone Monitoring System?

The FDA 510(k) record lists Apex BioTechnology Corp. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Apex BioTechnology Corp. as applicant

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Related Devices (Code: JIN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201551KetoSens BT Blood B-Ketone Monitoring SystemI-Sens, Inc.K192957VivaChek Blood Glucose and B-Ketone Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.K173345TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology CorporationK170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc.K170587On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for UrinalysisACON Laboratories, Inc.

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.

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