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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 a medical device manufactured by Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2016-02-24 under approval 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. It is manufactured by Randox Laboratories, Ltd.. The 510(k) number is K152085.

When was Liquid CO2-2 (LCO2-2) approved by the FDA?

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

What company makes Liquid CO2-2 (LCO2-2)?

Liquid CO2-2 (LCO2-2) is manufactured by Randox Laboratories, Ltd..

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

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

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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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