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FDA 510(k)

RANDOX BARITURATES ASSAY

K-Number: K092268 · 2011-05-25

ApplicantRandox Laboratories, Ltd.
Decision Date2011-05-25
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RANDOX BARITURATES 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 2011-05-25 under 510(k) number K092268. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX BARITURATES ASSAY?

RANDOX BARITURATES ASSAY is a medical device that received FDA 510(k) clearance on 2011-05-25. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K092268.

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

RANDOX BARITURATES ASSAY received FDA 510(k) clearance on 2011-05-25, under 510(k) number K092268.

Who is the listed applicant for RANDOX BARITURATES 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 BARITURATES ASSAY?

The FDA product code for RANDOX BARITURATES ASSAY is DIS.

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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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