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FDA 510(k)

RANDOX ETHANOL ASSAY

K-Number: K092273 · 2010-11-01

ApplicantRandox Laboratories, Ltd.
Decision Date2010-11-01
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RANDOX ETHANOL ASSAY 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 2010-11-01 under 510(k) number K092273. The device is classified under product code DIC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX ETHANOL ASSAY?

RANDOX ETHANOL ASSAY is a medical device that received FDA 510(k) clearance on 2010-11-01. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K092273.

When did RANDOX ETHANOL ASSAY receive FDA 510(k) clearance?

RANDOX ETHANOL ASSAY received FDA 510(k) clearance on 2010-11-01, under 510(k) number K092273.

Who is the listed applicant for RANDOX ETHANOL ASSAY?

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 RANDOX ETHANOL ASSAY?

The FDA product code for RANDOX ETHANOL ASSAY is DIC.

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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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