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FDA 510(k)

KETOREX SANWA STANDARDS

K-Number: K903365 · 1990-12-20

ApplicantIhara Medics U.S., Inc.
Decision Date1990-12-20
Product CodeJIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KETOREX SANWA STANDARDS 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 1990-12-20 under 510(k) number K903365. 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 KETOREX SANWA STANDARDS?

KETOREX SANWA STANDARDS is a medical device that received FDA 510(k) clearance on 1990-12-20. The listed applicant is Ihara Medics U.S., Inc.. The 510(k) number is K903365.

When did KETOREX SANWA STANDARDS receive FDA 510(k) clearance?

KETOREX SANWA STANDARDS received FDA 510(k) clearance on 1990-12-20, under 510(k) number K903365.

Who is the listed applicant for KETOREX SANWA STANDARDS?

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 KETOREX SANWA STANDARDS?

The FDA product code for KETOREX SANWA STANDARDS is JIN.

Related Clinical Trials

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.

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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 SANWAK912373KETO-340 IIK903366KETONE 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

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

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