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FDA 510(k)

URIC ACID, BOUND ENZYME

K-Number: K790092 · 1979-03-12

ApplicantTechnicon Instruments Corp.
Decision Date1979-03-12
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID, BOUND ENZYME is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1979-03-12 under 510(k) number K790092. 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, BOUND ENZYME?

URIC ACID, BOUND ENZYME is a medical device that received FDA 510(k) clearance on 1979-03-12. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K790092.

When did URIC ACID, BOUND ENZYME receive FDA 510(k) clearance?

URIC ACID, BOUND ENZYME received FDA 510(k) clearance on 1979-03-12, under 510(k) number K790092.

Who is the listed applicant for URIC ACID, BOUND ENZYME?

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

What is the FDA product code for URIC ACID, BOUND ENZYME?

The FDA product code for URIC ACID, BOUND ENZYME is KNK.

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Other records listing Technicon Instruments Corp. as applicant

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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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