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FDA 510(k)

URIC ACID (URICASE) REAGENT, UNIVERSAL

K-Number: K912028 · 1991-12-18

ApplicantEnzyme Technology, Inc.
Decision Date1991-12-18
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID (URICASE) REAGENT, UNIVERSAL is the device name listed in this FDA 510(k) record. The listed applicant is Enzyme Technology, Inc.. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K912028. 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 (URICASE) REAGENT, UNIVERSAL?

URIC ACID (URICASE) REAGENT, UNIVERSAL is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Enzyme Technology, Inc.. The 510(k) number is K912028.

When did URIC ACID (URICASE) REAGENT, UNIVERSAL receive FDA 510(k) clearance?

URIC ACID (URICASE) REAGENT, UNIVERSAL received FDA 510(k) clearance on 1991-12-18, under 510(k) number K912028.

Who is the listed applicant for URIC ACID (URICASE) REAGENT, UNIVERSAL?

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

What is the FDA product code for URIC ACID (URICASE) REAGENT, UNIVERSAL?

The FDA product code for URIC ACID (URICASE) REAGENT, UNIVERSAL is KNK.

Related Clinical Trials

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.

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Other records listing Enzyme Technology, 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.

K912027CALCIUM (ARSENAZO III) REAGENT, UNIVERSALK905227GLUCOSE (HK) REAGENT, UNIVERSALK905226TRIGLYCERIDE (GPO) REAGENT, UNIVERSALK896073CHOLESTEROL, UNIVERSAL ET

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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