FDA 510(k)

Carbon Dioxide Reagent Set

K-Number: K170200 · 2017-06-01

Decision Date2017-06-01

Product CodeKHS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Carbon Dioxide Reagent Set 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 2017-06-01 under 510(k) number K170200. The device is classified under product code KHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Carbon Dioxide Reagent Set?

Carbon Dioxide Reagent Set is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Teco Diagnostics, Inc.. The 510(k) number is K170200.

When did Carbon Dioxide Reagent Set receive FDA 510(k) clearance?

Carbon Dioxide Reagent Set received FDA 510(k) clearance on 2017-06-01, under 510(k) number K170200.

Who is the listed applicant for Carbon Dioxide Reagent Set?

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 Carbon Dioxide Reagent Set?

The FDA product code for Carbon Dioxide Reagent Set is KHS.

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 System K161527Teco Creatinine Enzymatic Reagent Kit K160372URITEK TC-201 URINE CHEMISTRY TEST SYSTEM K152835URITEK TC-201 URINE CHEMISTRY TEST SYSTEM

Related Devices (Code: KHS)

K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd.

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.