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FDA 510(k)

Scanostics UTI Check Application Test System

K-Number: K170118 · 2017-09-21

ApplicantTeco Diagnostics
Decision Date2017-09-21
Product CodeJMT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Scanostics UTI Check Application Test System is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 2017-09-21 under 510(k) number K170118. The device is classified under product code JMT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Scanostics UTI Check Application Test System?

Scanostics UTI Check Application Test System is a medical device that received FDA 510(k) clearance on 2017-09-21. The listed applicant is Teco Diagnostics. The 510(k) number is K170118.

When did Scanostics UTI Check Application Test System receive FDA 510(k) clearance?

Scanostics UTI Check Application Test System received FDA 510(k) clearance on 2017-09-21, under 510(k) number K170118.

Who is the listed applicant for Scanostics UTI Check Application Test System?

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 Scanostics UTI Check Application Test System?

The FDA product code for Scanostics UTI Check Application Test System is JMT.

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.

NCT06976125Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulatory SettingRECRUITING

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.

K161527Teco Creatinine Enzymatic Reagent KitK170200Carbon Dioxide Reagent SetK160372URITEK TC-201 URINE CHEMISTRY TEST SYSTEMK152835URITEK TC-201 URINE CHEMISTRY TEST SYSTEM

Related Devices (Code: JMT)

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.

K251800Healgen® URS Test StripsHealgen Scientific,, LLCK252607AllTest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.K242767Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd.

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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