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FDA 510(k)

URIC-ACID TEST ENZYMATIC COLORIMETRIC

K-Number: K831864 · 1983-07-22

ApplicantStanbio Laboratory
Decision Date1983-07-22
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC-ACID TEST ENZYMATIC COLORIMETRIC is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1983-07-22 under 510(k) number K831864. 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 TEST ENZYMATIC COLORIMETRIC?

URIC-ACID TEST ENZYMATIC COLORIMETRIC is a medical device that received FDA 510(k) clearance on 1983-07-22. The listed applicant is Stanbio Laboratory. The 510(k) number is K831864.

When did URIC-ACID TEST ENZYMATIC COLORIMETRIC receive FDA 510(k) clearance?

URIC-ACID TEST ENZYMATIC COLORIMETRIC received FDA 510(k) clearance on 1983-07-22, under 510(k) number K831864.

Who is the listed applicant for URIC-ACID TEST ENZYMATIC COLORIMETRIC?

The FDA 510(k) record lists Stanbio Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URIC-ACID TEST ENZYMATIC COLORIMETRIC?

The FDA product code for URIC-ACID TEST ENZYMATIC COLORIMETRIC is KNK.

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Other records listing Stanbio Laboratory 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.

K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMK081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMK050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORK050283CREATININE LIQUICOLORK042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERK041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY

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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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