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FDA 510(k)

RANDOX BENZODIAZEPINE CLASS ASSAY

K-Number: K050179 · 2005-05-17

ApplicantRandox Laboratories, Ltd.
Decision Date2005-05-17
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RANDOX BENZODIAZEPINE 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 2005-05-17 under 510(k) number K050179. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX BENZODIAZEPINE CLASS ASSAY?

RANDOX BENZODIAZEPINE CLASS ASSAY is a medical device that received FDA 510(k) clearance on 2005-05-17. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K050179.

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

RANDOX BENZODIAZEPINE CLASS ASSAY received FDA 510(k) clearance on 2005-05-17, under 510(k) number K050179.

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

The FDA product code for RANDOX BENZODIAZEPINE CLASS ASSAY is JXM.

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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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