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FDA 510(k)

Liquid CO2-2 (LCO2-2)

K-Number: K152085 · 2016-02-24

ApplicantRandox Laboratories, Ltd.
Decision Date2016-02-24
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Liquid CO2-2 (LCO2-2) is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2016-02-24 under 510(k) number K152085. 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 Liquid CO2-2 (LCO2-2)?

Liquid CO2-2 (LCO2-2) is a medical device that received FDA 510(k) clearance on 2016-02-24. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K152085.

When did Liquid CO2-2 (LCO2-2) receive FDA 510(k) clearance?

Liquid CO2-2 (LCO2-2) received FDA 510(k) clearance on 2016-02-24, under 510(k) number K152085.

Who is the listed applicant for Liquid CO2-2 (LCO2-2)?

The FDA 510(k) record lists Randox Laboratories, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Liquid CO2-2 (LCO2-2)?

The FDA product code for Liquid CO2-2 (LCO2-2) is KHS.

Other records listing Randox Laboratories, Ltd. as applicant

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Related Devices (Code: KHS)

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.

K170200Carbon Dioxide Reagent SetTeco 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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