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FDA 510(k)

URITEK TC-201 URINE CHEMISTRY TEST SYSTEM

K-Number: K152835 · 2016-03-07

ApplicantTeco Diagnostics, Inc.
Decision Date2016-03-07
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URITEK TC-201 URINE CHEMISTRY TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-03-07 under 510(k) number K152835. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URITEK TC-201 URINE CHEMISTRY TEST SYSTEM?

URITEK TC-201 URINE CHEMISTRY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2016-03-07. The listed applicant is Teco Diagnostics, Inc.. The 510(k) number is K152835.

When did URITEK TC-201 URINE CHEMISTRY TEST SYSTEM receive FDA 510(k) clearance?

URITEK TC-201 URINE CHEMISTRY TEST SYSTEM received FDA 510(k) clearance on 2016-03-07, under 510(k) number K152835.

Who is the listed applicant for URITEK TC-201 URINE CHEMISTRY TEST SYSTEM?

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

What is the FDA product code for URITEK TC-201 URINE CHEMISTRY TEST SYSTEM?

The FDA product code for URITEK TC-201 URINE CHEMISTRY TEST SYSTEM is JFY.

Other records listing Teco 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.

K170118Scanostics UTI Check Application Test SystemK161527Teco Creatinine Enzymatic Reagent KitK170200Carbon Dioxide Reagent SetK160372URITEK TC-201 URINE CHEMISTRY TEST SYSTEM

Related Devices (Code: JFY)

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.

K252619QSCHECK UISACRQstag, Inc.K212223Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, Inc.K193649Yumizen C1200 Creatinine PAPHORIBA ABX SASK182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd.K183555GEM Premier ChemSTATInstrumentation Laboratory COK182038URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerYd Diagnostics Corporation

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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