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FDA 510(k)

RANDOX URIC ACID

K-Number: K033278 · 2004-02-27

ApplicantRandox Laboratories, Ltd.
Decision Date2004-02-27
Product CodeCDO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RANDOX URIC ACID 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 2004-02-27 under 510(k) number K033278. The device is classified under product code CDO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX URIC ACID?

RANDOX URIC ACID is a medical device that received FDA 510(k) clearance on 2004-02-27. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K033278.

When did RANDOX URIC ACID receive FDA 510(k) clearance?

RANDOX URIC ACID received FDA 510(k) clearance on 2004-02-27, under 510(k) number K033278.

Who is the listed applicant for RANDOX URIC ACID?

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 URIC ACID?

The FDA product code for RANDOX URIC ACID is CDO.

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Other records listing Randox Laboratories, Ltd. as applicant

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Related Devices (Code: CDO)

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.

K992798SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100PSigma Diagnostics, Inc.K982251SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KITSigma Diagnostics, Inc.K981766URIC ACIDAbbott LaboratoriesK981189URIC ACIDAbbott LaboratoriesK971485URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K955752OLYMPUS URIC ACID REAGENTOlympus America, Inc.

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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