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FDA 510(k)

KETO-340 II

K-Number: K912373 · 1991-07-01

ApplicantIhara Medics U.S., Inc.
Decision Date1991-07-01
Product CodeJIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KETO-340 II is the device name listed in this FDA 510(k) record. The listed applicant is Ihara Medics U.S., Inc.. It received FDA 510(k) clearance on 1991-07-01 under 510(k) number K912373. 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 KETO-340 II?

KETO-340 II is a medical device that received FDA 510(k) clearance on 1991-07-01. The listed applicant is Ihara Medics U.S., Inc.. The 510(k) number is K912373.

When did KETO-340 II receive FDA 510(k) clearance?

KETO-340 II received FDA 510(k) clearance on 1991-07-01, under 510(k) number K912373.

Who is the listed applicant for KETO-340 II?

The FDA 510(k) record lists Ihara Medics U.S., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KETO-340 II?

The FDA product code for KETO-340 II is JIN.

Other records listing Ihara Medics U.S., Inc. as applicant

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.

K953452KETOREX C SANWAK903365KETOREX SANWA STANDARDSK903366KETONE TEST B SANWA STANDARDK903367KETONE TEST A SANWA STANDARD

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.K182593KET-1 Blood Ketone Monitoring SystemApex BioTechnology Corp.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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