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FDA 510(k)

RANDOX RX DAYTONA

K-Number: K024014 · 2003-12-04

ApplicantRandox Laboratories, Ltd.
Decision Date2003-12-04
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RANDOX RX DAYTONA 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 2003-12-04 under 510(k) number K024014. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX RX DAYTONA?

RANDOX RX DAYTONA is a medical device that received FDA 510(k) clearance on 2003-12-04. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K024014.

When did RANDOX RX DAYTONA receive FDA 510(k) clearance?

RANDOX RX DAYTONA received FDA 510(k) clearance on 2003-12-04, under 510(k) number K024014.

Who is the listed applicant for RANDOX RX DAYTONA?

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 RX DAYTONA?

The FDA product code for RANDOX RX DAYTONA is CGA.

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Other records listing Randox Laboratories, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: CGA)

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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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