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FDA 510(k)

RANDOX OPIATES ASSAY

K-Number: K041144 · 2004-11-03

ApplicantRandox Laboratories, Ltd.
Decision Date2004-11-03
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RANDOX OPIATES 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 2004-11-03 under 510(k) number K041144. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX OPIATES ASSAY?

RANDOX OPIATES ASSAY is a medical device that received FDA 510(k) clearance on 2004-11-03. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K041144.

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

RANDOX OPIATES ASSAY received FDA 510(k) clearance on 2004-11-03, under 510(k) number K041144.

Who is the listed applicant for RANDOX OPIATES 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 OPIATES ASSAY?

The FDA product code for RANDOX OPIATES ASSAY is DJG.

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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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