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FDA 510(k)

Teco Creatinine Enzymatic Reagent Kit

K-Number: K161527 · 2017-07-21

ApplicantTeco Diagnostics, Inc.
Decision Date2017-07-21
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Teco Creatinine Enzymatic Reagent Kit 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 2017-07-21 under 510(k) number K161527. 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 Teco Creatinine Enzymatic Reagent Kit?

Teco Creatinine Enzymatic Reagent Kit is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Teco Diagnostics, Inc.. The 510(k) number is K161527.

When did Teco Creatinine Enzymatic Reagent Kit receive FDA 510(k) clearance?

Teco Creatinine Enzymatic Reagent Kit received FDA 510(k) clearance on 2017-07-21, under 510(k) number K161527.

Who is the listed applicant for Teco Creatinine Enzymatic Reagent Kit?

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 Teco Creatinine Enzymatic Reagent Kit?

The FDA product code for Teco Creatinine Enzymatic Reagent Kit 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 SystemK170200Carbon Dioxide Reagent SetK160372URITEK TC-201 URINE CHEMISTRY TEST SYSTEMK152835URITEK 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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