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FDA 510(k)

URIC ACID ENZYMATIC COLORIMERIC KIT

K-Number: K923503 · 1993-07-22

ApplicantRandox Laboratories, Ltd.
Decision Date1993-07-22
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID ENZYMATIC COLORIMERIC KIT 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 1993-07-22 under 510(k) number K923503. The device is classified under product code KNK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URIC ACID ENZYMATIC COLORIMERIC KIT?

URIC ACID ENZYMATIC COLORIMERIC KIT is a medical device that received FDA 510(k) clearance on 1993-07-22. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K923503.

When did URIC ACID ENZYMATIC COLORIMERIC KIT receive FDA 510(k) clearance?

URIC ACID ENZYMATIC COLORIMERIC KIT received FDA 510(k) clearance on 1993-07-22, under 510(k) number K923503.

Who is the listed applicant for URIC ACID ENZYMATIC COLORIMERIC KIT?

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 URIC ACID ENZYMATIC COLORIMERIC KIT?

The FDA product code for URIC ACID ENZYMATIC COLORIMERIC KIT is KNK.

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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.

K230890ISE ElectrodesK182042Randox Calcium (Ca)K162200Randox RX Daytona Plus Magnesium (MG)K152085Liquid CO2-2 (LCO2-2)K153435Direct HDL Cholesterol (HDL)K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

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Related Devices (Code: KNK)

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.

K102568URIC ACID MODEL 3P39Abbott LaboratoriesK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98Olympus America, Inc.K040467VITALAB URIC ACID REAGENTClinical Data, Inc.K031044ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATORClinical Data, Inc.K022096URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.K023550WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDAWiener Laboratories Saic

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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