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FDA 510(k)

URITEK TC-201 URINE CHEMISTRY TEST SYSTEM

K-Number: K160372 · 2016-07-22

ApplicantTeco Diagnostics, Inc.
Decision Date2016-07-22
Product CodeJIL
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 2016-07-22 under approval number K160372. The device is classified under product code JIL. 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 2016-07-22. It is manufactured by Teco Diagnostics, Inc.. The 510(k) number is K160372.

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 2016-07-22, under approval number K160372.

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 JIL.

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Other Devices by Teco Diagnostics, Inc.

K152835URITEK TC-201 URINE CHEMISTRY TEST SYSTEM K161527Teco Creatinine Enzymatic Reagent Kit K170200Carbon Dioxide Reagent Set

Related Devices (Code: JIL)

K160062AUTION ELEVEN Semi-Automated Urinalysis SystemArkray, Inc. K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. K173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd. K180356inui In-Home Urine Analysis Test SystemScanadu, Inc. K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd. K171521DUS R-50S (Urine Chemistry system)DFI 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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