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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 a medical device manufactured by Teco Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-03-07 under approval 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. It is manufactured by Teco Diagnostics, Inc.. The 510(k) number is K152835.

When was URITEK TC-201 URINE CHEMISTRY TEST SYSTEM approved by the FDA?

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

What company makes URITEK TC-201 URINE CHEMISTRY TEST SYSTEM?

URITEK TC-201 URINE CHEMISTRY TEST SYSTEM is manufactured by Teco Diagnostics, Inc..

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.

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Other Devices by Teco Diagnostics, Inc.

K160372URITEK TC-201 URINE CHEMISTRY TEST SYSTEM K161527Teco Creatinine Enzymatic Reagent Kit K170200Carbon Dioxide Reagent Set

Related Devices (Code: JFY)

K161527Teco Creatinine Enzymatic Reagent KitTeco Diagnostics, Inc. K182038URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerYd Diagnostics Corporation K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc. K182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd. K183555GEM Premier ChemSTATInstrumentation Laboratory CO K212223Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, 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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