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FDA 510(k)

RANDOX AMPHETAMINE CLASS ASSAY

K-Number: K040350 · 2004-05-12

ApplicantRandox Laboratories, Ltd.
Decision Date2004-05-12
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RANDOX AMPHETAMINE CLASS 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 2004-05-12 under 510(k) number K040350. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX AMPHETAMINE CLASS ASSAY?

RANDOX AMPHETAMINE CLASS ASSAY is a medical device that received FDA 510(k) clearance on 2004-05-12. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K040350.

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

RANDOX AMPHETAMINE CLASS ASSAY received FDA 510(k) clearance on 2004-05-12, under 510(k) number K040350.

Who is the listed applicant for RANDOX AMPHETAMINE CLASS 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 AMPHETAMINE CLASS ASSAY?

The FDA product code for RANDOX AMPHETAMINE CLASS ASSAY is DKZ.

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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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