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FDA 510(k)

URIC ACID COLORIMETRIC DETERMINATION

K-Number: K830679 · 1983-04-06

ApplicantDow Instruments & Reagents, Inc.
Decision Date1983-04-06
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID COLORIMETRIC DETERMINATION is the device name listed in this FDA 510(k) record. The listed applicant is Dow Instruments & Reagents, Inc.. It received FDA 510(k) clearance on 1983-04-06 under 510(k) number K830679. 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 COLORIMETRIC DETERMINATION?

URIC ACID COLORIMETRIC DETERMINATION is a medical device that received FDA 510(k) clearance on 1983-04-06. The listed applicant is Dow Instruments & Reagents, Inc.. The 510(k) number is K830679.

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

URIC ACID COLORIMETRIC DETERMINATION received FDA 510(k) clearance on 1983-04-06, under 510(k) number K830679.

Who is the listed applicant for URIC ACID COLORIMETRIC DETERMINATION?

The FDA 510(k) record lists Dow Instruments & Reagents, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URIC ACID COLORIMETRIC DETERMINATION?

The FDA product code for URIC ACID COLORIMETRIC DETERMINATION is KNK.

Related Clinical Trials

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Other records listing Dow Instruments & Reagents, 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.

K830469BILIRUBIN STANDARD-LYOPHILIZED

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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