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FDA 510(k)

IN-VITRO TEST DETERMINATION OF URIC ACID

K-Number: K854185 · 1985-11-25

ApplicantClinical Data, Inc.
Decision Date1985-11-25
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IN-VITRO TEST DETERMINATION OF URIC ACID 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 1985-11-25 under 510(k) number K854185. 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 IN-VITRO TEST DETERMINATION OF URIC ACID?

IN-VITRO TEST DETERMINATION OF URIC ACID is a medical device that received FDA 510(k) clearance on 1985-11-25. The listed applicant is Clinical Data, Inc.. The 510(k) number is K854185.

When did IN-VITRO TEST DETERMINATION OF URIC ACID receive FDA 510(k) clearance?

IN-VITRO TEST DETERMINATION OF URIC ACID received FDA 510(k) clearance on 1985-11-25, under 510(k) number K854185.

Who is the listed applicant for IN-VITRO TEST DETERMINATION OF URIC ACID?

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 IN-VITRO TEST DETERMINATION OF URIC ACID?

The FDA product code for IN-VITRO TEST DETERMINATION OF URIC ACID is KNK.

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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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