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FDA 510(k)

URS-1K (KETONE TESST)

K-Number: K003987 · 2001-04-26

ApplicantTeco Diagnostics
Decision Date2001-04-26
Product CodeJIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URS-1K (KETONE TESST) is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 2001-04-26 under 510(k) number K003987. 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 URS-1K (KETONE TESST)?

URS-1K (KETONE TESST) is a medical device that received FDA 510(k) clearance on 2001-04-26. The listed applicant is Teco Diagnostics. The 510(k) number is K003987.

When did URS-1K (KETONE TESST) receive FDA 510(k) clearance?

URS-1K (KETONE TESST) received FDA 510(k) clearance on 2001-04-26, under 510(k) number K003987.

Who is the listed applicant for URS-1K (KETONE TESST)?

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

What is the FDA product code for URS-1K (KETONE TESST)?

The FDA product code for URS-1K (KETONE TESST) is JIN.

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Other records listing Teco Diagnostics 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.

K170118Scanostics UTI Check Application Test SystemK111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTK100024TECO DIAGNOSTICS UTI DETECTION STRIPSK101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERK072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440

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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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