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FDA 510(k)

VITALAB URIC ACID REAGENT

K-Number: K040467 · 2004-03-08

ApplicantClinical Data, Inc.
Decision Date2004-03-08
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITALAB URIC ACID REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Data, Inc.. It received FDA 510(k) clearance on 2004-03-08 under 510(k) number K040467. 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 VITALAB URIC ACID REAGENT?

VITALAB URIC ACID REAGENT is a medical device that received FDA 510(k) clearance on 2004-03-08. The listed applicant is Clinical Data, Inc.. The 510(k) number is K040467.

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

VITALAB URIC ACID REAGENT received FDA 510(k) clearance on 2004-03-08, under 510(k) number K040467.

Who is the listed applicant for VITALAB URIC ACID REAGENT?

The FDA 510(k) record lists Clinical Data, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITALAB URIC ACID REAGENT?

The FDA product code for VITALAB URIC ACID REAGENT is KNK.

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Other records listing Clinical Data, Inc. 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.

K071706ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)K052591NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KITK033983VITALAB IRON REAGENTK040631VITALAB DIRECT BILIRUBIN REAGENTK040534VITALAB AMYLASE REAGENTK034000VITALAB TRIGLYCERIDES REAGENT AND VITALAB 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.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 SaicK012038JAS URIC ACID LIQUID REAGENTJas Diagnostics, 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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