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FDA 510(k)

KYOTEST UK URINE TEST REAGENT STRIP

K-Number: K841715 · 1984-05-31

ApplicantKyoto Diagnostics, Inc.
Decision Date1984-05-31
Product CodeJIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KYOTEST UK URINE TEST REAGENT STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Kyoto Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-05-31 under 510(k) number K841715. 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 KYOTEST UK URINE TEST REAGENT STRIP?

KYOTEST UK URINE TEST REAGENT STRIP is a medical device that received FDA 510(k) clearance on 1984-05-31. The listed applicant is Kyoto Diagnostics, Inc.. The 510(k) number is K841715.

When did KYOTEST UK URINE TEST REAGENT STRIP receive FDA 510(k) clearance?

KYOTEST UK URINE TEST REAGENT STRIP received FDA 510(k) clearance on 1984-05-31, under 510(k) number K841715.

Who is the listed applicant for KYOTEST UK URINE TEST REAGENT STRIP?

The FDA 510(k) record lists Kyoto Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KYOTEST UK URINE TEST REAGENT STRIP?

The FDA product code for KYOTEST UK URINE TEST REAGENT STRIP is JIN.

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Other records listing Kyoto Diagnostics, 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.

K861733ADDITIONAL KYOTEST URINE TEST REAGENT STRIPSK843003GLUCOSE AUTO& STAT GA-1120K842750OSMOTIC PRESSURE AUTO & STAT OM-6010K842168ATAGO URINE SPECIFIC GRAVITY & SERUMK841714KYOTEST 2V, URINE TEST REAGENT STRIPK841713KYOTEST UG URINE TEST REAGENT STRIP

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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.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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